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compositionComposition:FLUMAZENIL-0.5MG
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FLUDOT 0.5MG/5ML INJECTION is used to treat benzodiazepine overdose (sedative poisoning) in adults. Besides this, it is used to help you wake up after a surgery or medical procedure, acting as a reversal of conscious sedation and general anaesthesia. It contains Flumazenil, a benzodiazepine antagonist. It inhibits the activity of benzodiazepine and non-benzodiazepine compounds that bind with benzodiazepine receptors on the GABA/benzodiazepine receptor complex.

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Written By Bayyarapu Mahesh Kumar , M Pharmacy
Reviewed By Dr Aneela Siddabathuni , MPharma., PhD
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More about the Product

Composition :

FLUMAZENIL-0.5MG

Manufacturer/Marketer :

Neon Laboratories Ltd

Consume Type :

Parenteral

Expires on or after :

Jan-27

Return Policy :

Not Returnable

About FLUDOT 0.5MG/5ML INJECTION

FLUDOT 0.5MG/5ML INJECTION is an injection used to reverse the sleepiness and calming effects of medicines called benzodiazepines. It is commonly used to help you wake up after surgery or medical tests where these sedatives were given. It is also used in emergencies to treat an accidental overdose of these specific medications.

Since this medicine is given directly into a vein by a doctor, you will not have a regular daily schedule. Food does not affect this injection, but you must follow your doctor's instructions about eating after surgery. Resting in a quiet room and staying hydrated will help you recover smoothly.

Many patients experience only mild side effects like sweating, flushing, or feeling slightly dizzy. However, you must alert your medical team immediately if you feel severe chest pain, rapid heartbeats, or uncontrollable shaking. It is vital to consult your doctor if these serious symptoms occur.

You must talk to your doctor before receiving this injection if you have a history of head injuries, liver damage, or severe anxiety. Specifically, individuals who have been taking sedatives for a long time to manage epilepsy should not receive this medicine, as it can trigger severe withdrawal seizures.

This medicine can interact with alcohol or other calming medications, potentially causing sudden withdrawal symptoms or severe agitation. Because of these risks, always consult your doctor if you are pregnant, breastfeeding, or an elderly individual before receiving this treatment.

Uses of FLUDOT 0.5MG/5ML INJECTION

Your doctor may prescribe FLUDOT 0.5MG/5ML INJECTION to help manage the following conditions:

  • Reversing sedation from medical procedures: FLUDOT 0.5MG/5ML INJECTION helps wake you up and restores alertness after you have received sedatives for surgeries, dental work, or diagnostic tests.
  • Treating sedative overdose: FLUDOT 0.5MG/5ML INJECTION helps reverse the dangerous effects, such as extreme sleepiness or slowed breathing, caused by taking too much benzodiazepine medicine.

Key Benefits

When used as directed as part of your treatment plan, this medicine may provide the following benefits:

  • Faster Recovery After Sedation: FLUDOT 0.5MG/5ML INJECTION provides rapid recovery from medical sedation, allowing you to wake up faster and feel more alert after a procedure. Quicker Return to Alertness: This helps you return to your normal state of awareness sooner and reduces the time you need to spend in the recovery room.
  • Reverses Sedative Overdose: In emergency situations, it helps restore normal breathing and consciousness quickly, which can be life-saving for patients experiencing a sedative overdose. It also allows healthcare providers to safely manage and reverse the effects of deep sedation once a procedure is successfully finished.
Side effects of Fludot 0.5 Injection 5 ml
Overcome Medication-Induced Nausea: A 9-Step Plan
  • Inform your doctor about the nausea and discuss possible alternatives to the medication or adjustments to the dosage.
  • Divide your daily food intake into smaller, more frequent meals to reduce nausea.
  • Opt for bland, easily digestible foods like crackers, toast, plain rice, bananas, and applesauce.
  • Avoid certain foods that can trigger nausea, such as fatty, greasy, spicy, and smelly foods.
  • Drink plenty of fluids, such as water, clear broth, or electrolyte-rich beverages like coconut water or sports drinks.
  • Use ginger (tea, ale, or candies) to help relieve nausea.
  • Get adequate rest and also avoid strenuous activities that can worsen nausea.
  • Talk to your doctor about taking anti-nausea medication if your nausea is severe.
  • Record when your nausea occurs, what triggers it, and what provides relief to help you identify patterns and manage your symptoms more effectively.
To prevent, manage, and treat Constipation caused by medication usage, follow these steps:
  • Preventing Vomiting (Before it Happens)
  • Take medication exactly as prescribed by your doctor. This can help minimize side effects, including vomiting.
  • Having a small meal before taking your medication can help reduce nausea and vomiting.
  • Talk to your doctor about taking anti-nausea medication along with your prescribed medication.
  • Managing Vomiting (If it Happens)
  • Try taking ginger in the form of tea, ale, or candy to help alleviate nausea and vomiting.
  • What to Do if Vomiting Persists
  • Consult your doctor if vomiting continues or worsens, consult the doctor for guidance on adjusting your medication or additional treatment.
Here are the seven steps to manage medication-triggered Dyspnea (Difficulty Breathing or Shortness of Breath):
  • Tell your doctor immediately if you experience shortness of breath after taking medication.
  • Your doctor may adjust the medication regimen or dosage or give alternative medical procedures to minimize the symptoms of shortness of breath.
  • Monitor your oxygen levels and breathing rate regularly to track changes and potential side effects.
  • For controlling stress and anxiety, try relaxation techniques like deep breathing exercises, meditation, or yoga.
  • Make lifestyle changes, such as quitting smoking, exercising regularly, and maintaining a healthy weight.
  • Seek emergency medical attention if you experience severe shortness of breath, chest pain, or difficulty speaking.
  • Follow up regularly with your doctor to monitor progress, adjust treatment plans, and address any concerns or questions.
Here are the steps to Dry Mouth (xerostomia) caused by medication:
  • Inform your doctor about dry mouth symptoms. They may adjust your medication regimen or prescribe additional medications to manage symptoms.
  • Drink plenty of water throughout the day to help keep your mouth moist and alleviate dry mouth symptoms.
  • Chew sugar-free gum or candies to increase saliva production and keep your mouth moisturized.
  • Use saliva substitutes, such as mouthwashes or sprays, only if your doctor advises them to help moisturize your mouth and alleviate dry mouth symptoms.
  • Avoid consuming smoking, alcohol, spicy or acidic foods, and other irritants that may aggravate dry mouth symptoms.
  • Schedule regular dental check-ups to keep track of your oral health and handle any dry mouth issues as they arise.
  • Always wear loose-fitting clothes which are suitable for your activity.
  • Include the diet containing fruits like watermelon, grapes, bananas and green leafy vegetables.
  • Drink plenty of water and stay hydrated.
  • Avoid moving more and staying in hot sun.

Directions for Use

  • Follow your doctor's instructions on the dosage and timing of this medication.
  • FLUDOT 0.5MG/5ML INJECTION will be administered by a healthcare professional.
  • Do not self-administer it.

How FLUDOT 0.5MG/5ML INJECTION Works

FLUDOT 0.5MG/5ML INJECTION works by acting as a shield in your brain. It blocks the specific docking stations, known as receptors, that sedative medicines use to make you feel sleepy or relaxed. By temporarily taking over these spots, FLUDOT 0.5MG/5ML INJECTION stops the sedatives from acting on your brain, which helps you wake up and restores your normal breathing and alertness.
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Alcohol

Caution

If you are still feeling drowsy or for at least 24 hours after taking FLUDOT 0.5MG/5ML INJECTION, avoid drinking alcohol.

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Pregnancy

Caution

The use of FLUDOT 0.5MG/5ML INJECTION in pregnant women has not been adequately and carefully studied. During pregnancy, FLUDOT 0.5MG/5ML INJECTION should only be used if the possible advantages outweigh the possible risks to the developing foetus.

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Breast Feeding

Caution

It is not known whether FLUDOT 0.5MG/5ML INJECTION passes into breastmilk. Hence, it should be used with caution in nursing mothers.

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Driving

Unsafe

Avoid driving or doing any other activity that requires you to be awake and alert for at least 24 hours after taking FLUDOT 0.5MG/5ML INJECTION. Your ability to react might be compromised. Limit these activities further until they stop making you feel sedated (weak, drowsy, or dizzy).

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Liver

Caution

FLUDOT 0.5MG/5ML INJECTION should be given with caution by initial and/or repeated dosing to patients with liver disease.

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Kidney

Caution

The effect of FLUDOT 0.5MG/5ML INJECTION was not significantly affected with renal impairment. However, inform the doctor if the patient has kidney problems.

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Children

Caution

There was limited information about the usage of FLUDOT 0.5MG/5ML INJECTION in paediatric patients. Please seek medical advice. Only if the benefits exceed the risks, your doctor may prescribe.

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Heart

Consult your doctor

Please inform your doctor if you have any pre-existing heart problems receiving using FLUDOT 0.5MG/5ML INJECTION. Your doctor will prescribe FLUDOT 0.5MG/5ML INJECTION if the benefits outweigh the risk.

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Geriatrics

Consult your doctor

Please consult a doctor before administering FLUDOT 0.5MG/5ML INJECTION to geriatric patients. Your doctor will prescribe FLUDOT 0.5MG/5ML INJECTION if the benefits outweigh the risks.

What if I have taken an overdose of FLUDOT 0.5MG/5ML INJECTION

This medicine is carefully measured and injected by healthcare professionals in a controlled hospital setting, making an overdose highly unlikely. However, if too much is given, it can cause severe anxiety, rapid heart rate, or seizures. The medical team will monitor you closely and treat any symptoms immediately.

Diet & Lifestyle Advise

  • Avoid Driving and Machinery: Do not drive, operate heavy machinery, or do tasks that require complete alertness for at least 24 hours after receiving FLUDOT 0.5MG/5ML INJECTION, as the effects of the original sedative can sometimes return.
  • Avoid Alcohol and Sedatives: Avoid drinking alcohol or taking any over-the-counter sleep aids or sedatives for at least 24 hours after your procedure, as they can cause dangerous sleepiness.
  • Rest with Adult Supervision: Rest quietly in a comfortable environment once you are discharged, and ensure a responsible adult stays with you to monitor your recovery.
  • Choose Light Meals: Eat light, easily digestible meals, such as toast or crackers, if you feel slightly nauseated after your procedure.

Health Queries

What is the immediate medical treatment and antidote for a Diazepam overdose involving 45 tablets?

Chandrakanta Jena

Chandrakanta Jena

Pharm D

An overdose of 45 diazepam tablets is a life-threatening medical emergency. Go to the nearest emergency room immediately; do not induce vomiting. Immediate hospital treatment focuses on supportive care, including airway management, oxygen, intravenous fluids, and continuous monitoring of vital signs. The specific antidote for benzodiazepines like diazepam is Flumazenil. However, doctors use Flumazenil with extreme caution because it can precipitate severe, potentially life-threatening seizures, especially in chronic users. Prompt, professional medical intervention is critical for survival.
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How Soon It Starts Working

The time required for FLUDOT 0.5MG/5ML INJECTION to start to work: FLUDOT 0.5MG/5ML INJECTION ideally shows its action within 1 to 2 minutes after administration. The time for which the effects of FLUDOT 0.5MG/5ML INJECTION last: The effect of FLUDOT 0.5MG/5ML INJECTION lasts for 19 to 50 minutes.

What if you forget to take FLUDOT 0.5MG/5ML INJECTION

Since this medicine is given only by a healthcare professional during a medical procedure or emergency, you will not have a regular dosing schedule at home, and there is no risk of missing a dose.

Storage

• Store this medication at room temperature, ideally between 20°C and 25°C (68°F to 77°F).

Drug Warnings

  • Share Your Medical History: Ensure your medical team knows if you have a history of seizures, epilepsy, or head injuries before receiving this injection.
  • Check the Injection Solution: The healthcare professional must inspect the vial before use; the solution must be clear, colourless, and free of visible particles.
  • Watch for Returning Drowsiness: Be aware that the effects of the original sedative can sometimes last longer than FLUDOT 0.5MG/5ML INJECTION, meaning you might become sleepy again after initially waking up.
  • Move Slowly After Treatment: Avoid sudden movements or standing up too quickly immediately after receiving the injection to prevent dizziness or fainting.
  • Report Injection Site Reactions: Inform the medical team immediately if you experience any pain, burning, redness, or swelling at the injection site.

Drug-Drug Interactions

verifiedApollotooltip
  • Tricyclic Antidepressants: Combining FLUDOT 0.5MG/5ML INJECTION with tricyclic antidepressants may increase the risk of seizures and other serious adverse effects.
  • Benzodiazepines: FLUDOT 0.5MG/5ML INJECTION may reduce the effectiveness of benzodiazepines such as diazepam, alprazolam, or lorazepam. Do not stop benzodiazepines suddenly, as abrupt withdrawal can cause serious symptoms, including seizures.
FlumazenilClomipramine
Severe
FlumazenilAmitriptyline
Severe

Drug-Drug Interactions

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FlumazenilClomipramine
Severe
How does the drug interact with Fludot 0.5 Injection 5 ml:
Co-administration of Fludot 0.5 Injection 5 ml with clomipramine can increase the risk of irregular heart rhythm., seizures(fits).

How to manage the interaction:
Although taking clomipramine and Fludot 0.5 Injection 5 ml together can cause an interaction, it can be taken if your doctor has suggested it. if you experience dizziness, lightheadedness, fainting, shortness of breath, or heart palpitations contact your doctor immediately. Do not discontinue any medications without consulting a doctor.
FlumazenilAmitriptyline
Severe
How does the drug interact with Fludot 0.5 Injection 5 ml:
Coadministration of Fludot 0.5 Injection 5 ml and amitriptyline together can result in irregular heartbeat and seizures (fits).

How to manage the interaction:
Although there is an interaction between amitriptyline and Fludot 0.5 Injection 5 ml, they can be taken together if prescribed by a doctor. Do not discontinue any medications without consulting a doctor
FlumazenilLorazepam
Severe
How does the drug interact with Fludot 0.5 Injection 5 ml:
Co-administration of Fludot 0.5 Injection 5 ml with lorazepam can increase the risk of seizures(fits).

How to manage the interaction:
Although there is a possible interaction between Fludot 0.5 Injection 5 ml and Lorazepam, you can take these medicines together if prescribed by your doctor. Do not stop using any medications without a doctor's advice.
FlumazenilProtriptyline
Severe
How does the drug interact with Fludot 0.5 Injection 5 ml:
Using Fludot 0.5 Injection 5 ml together with protriptyline can increase the risk of abnormal heart rhythm.

How to manage the interaction:
There may be a possibility of interaction between Fludot 0.5 Injection 5 ml and Protriptyline, but it can be taken if prescribed by a doctor. If you experience irregular heartbeat, chest tightness, blurred vision, nausea, and seizures contact your doctor right away. Do not stop using any medications without first talking to your doctor.
FlumazenilNortriptyline
Severe
How does the drug interact with Fludot 0.5 Injection 5 ml:
Coadministration of Nortriptyline with Fludot 0.5 Injection 5 ml can increase the risk or severity of irregular heart rhythms which can lead to seizures.

How to manage the interaction:
Taking Nortriptyline with Fludot 0.5 Injection 5 ml together can result in an interaction, it can be taken if your doctor has advised it. However, if you experience sudden dizziness, lightheadedness, fainting, shortness of breath, chest pain or tightness, blurred vision, nausea, seizures rapid heartbeat, or memory loss, contact a doctor immediately. Do not discontinue any medications without consulting a doctor.
FlumazenilImipramine
Severe
How does the drug interact with Fludot 0.5 Injection 5 ml:
Taking Fludot 0.5 Injection 5 ml and imipramine can affect the rhythm of your heart and possibly cause seizures.

How to manage the interaction:
Although taking Fludot 0.5 Injection 5 ml and Imipramine together can cause an interaction, it can be taken if your doctor has suggested it. If you experience irregular heartbeat, chest tightness, blurred vision, nausea, and seizures contact a doctor immediately. Do not stop using any medications without talking to a doctor.
FlumazenilDoxepin
Severe
How does the drug interact with Fludot 0.5 Injection 5 ml:
The combined use of Fludot 0.5 Injection 5 ml and Doxepin can affect the rhythm of your heart and possibly cause seizures.

How to manage the interaction:
Co-administration of Fludot 0.5 Injection 5 ml and Doxepin can lead to an interaction, it can be taken if advised by your doctor. However, if you experience any symptoms like irregular heartbeat, chest tightness, blurred vision, nausea, and seizures, contact your doctor immediately. Do not discontinue any medications without first consulting your doctor.
FlumazenilTrimipramine
Severe
How does the drug interact with Fludot 0.5 Injection 5 ml:
Combining Fludot 0.5 Injection 5 ml together with trimipramine can increase the risk of abnormal heart rhythm.

How to manage the interaction:
Although taking Fludot 0.5 Injection 5 ml and Trimipramine together can evidently cause an interaction, it can be taken if your doctor has suggested it. If you experience irregular heartbeat, chest tightness, blurred vision, nausea and seizures contact your doctor right away. Do not discontinue any medications without first consulting your doctor.
FlumazenilChlordiazepoxide
Severe
How does the drug interact with Fludot 0.5 Injection 5 ml:
Co-administration of Fludot 0.5 Injection 5 ml with Chlordiazepoxide can increase the risk of developing fits.

How to manage the interaction:
Taking Fludot 0.5 Injection 5 ml and chlordiazepoxide together can result in an interaction, it can be taken if your doctor has advised it. However, if you experience dizziness, drowsiness, difficulty concentrating, or blurred vision, consult a doctor immediately. Do not discontinue any medications without consulting a doctor.
FlumazenilMaprotiline
Severe
How does the drug interact with Fludot 0.5 Injection 5 ml:
Using Fludot 0.5 Injection 5 ml together with maprotiline can increase the risk of abnormal heart rhythm and seizures(fits).

How to manage the interaction:
Although there is a interaction between Fludot 0.5 Injection 5 ml and Maprotiline, but it can be taken if prescribed by a doctor. If you experience irregular heartbeat, chest tightness, blurred vision, nausea, and seizures contact your doctor right away. Do not stop using any medications without a doctor's advice.

Drug-Food Interactions

verifiedApollotooltip
  • There are no known direct interactions with food, but you must avoid consuming alcohol for at least 24 hours after receiving this injection to prevent severe drowsiness.
No Drug - Food interactions found in our database. Some may be unknown. Consult your doctor for what to avoid during medication.

Drug-Food Interactions

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Habit Forming

No

Therapeutic Class

[ANTIDOTES]

FAQs

FLUDOT 0.5MG/5ML INJECTION is used to treat Benzodiazepine overdose in adults.
FLUDOT 0.5MG/5ML INJECTION contains Flumazenil a benzodiazepine antagonist. It inhibits the activity of benzodiazepine and non-benzodiazepine compounds that bind with benzodiazepine receptors on the GABA/benzodiazepine receptor complex.
Flumazenil: an antidote for benzodiazepine poisoning.
No. FLUDOT 0.5MG/5ML INJECTION does not have the potential for habit forming.
FLUDOT 0.5MG/5ML INJECTION effects start within 1-2 minutes after injection. Most of the response (approx 80%) occurs within the first 3 minutes, with the peak effect between 6-10 minutes after administration.
The recommended duration of taking FLUDOT 0.5MG/5ML INJECTION is typically limited to a single dose or a short course of treatment, usually in a medical setting. The duration of action is relatively short, depending on the individual and the dose.
Common or reported side effects of FLUDOT 0.5MG/5ML INJECTION may include nausea, vomiting, headache, dizziness, sweating, flushing, anxiety, agitation, and pain or irritation at the injection site. Most side effects are temporary. Tell your doctor or nurse if symptoms are severe or persistent. Seizures are a serious but uncommon risk, particularly in people who are dependent on benzodiazepines or in certain overdose situations.
No. Although FLUDOT 0.5MG/5ML INJECTION can quickly reverse the sedative effects of benzodiazepines, the effects of the original benzodiazepine may return after FLUDOT 0.5MG/5ML INJECTION wears off. Arrange for a responsible adult to drive you home, and avoid driving, operating machinery, or other activities requiring alertness for at least 24 hours after receiving FLUDOT 0.5MG/5ML INJECTION. Follow your healthcare professional's specific advice.
FLUDOT 0.5MG/5ML INJECTION is only used during pregnancy if the potential benefit justifies the potential risk to the unborn baby, such as in life-threatening emergencies. If you are pregnant or planning to become pregnant, talk to your doctor about the risks.
No, FLUDOT 0.5MG/5ML INJECTION specifically reverses the effects of benzodiazepine sedatives. It does not reverse the effects of other drugs, such as opioids, alcohol, or barbiturates. Talk to your doctor or emergency medical team for more information.
Yes, if you take benzodiazepines regularly for anxiety, sleep, or seizures, FLUDOT 0.5MG/5ML INJECTION can cause sudden and severe withdrawal symptoms, including seizures and extreme anxiety. Talk to your doctor or pharmacist about your complete medical history.
The effects usually last for about 1 to 3 hours. Because some sedatives stay in your body longer than FLUDOT 0.5MG/5ML INJECTION, you may become sleepy again as the medicine wears off. Your healthcare team will monitor you closely during this time. Talk to your doctor if you feel unusually tired.
It is not fully known if this medicine passes into breast milk. You should talk to your doctor about whether to temporarily stop breastfeeding or pump and discard your milk for a short period after receiving this injection.
Some mild pain, redness, or swelling at the injection site is common and usually goes away quickly. However, if the pain worsens, or if you notice severe swelling or warmth, tell your doctor or nurse immediately.

Disclaimer

While we strive to provide complete, accurate, and expert-reviewed content on our 'Platform', we make no warranties or representations and disclaim all responsibility and liability for the completeness, accuracy, or reliability of the aforementioned content. The content on our platform is for informative purposes only, and may not cover all clinical/non-clinical aspects. Reliance on any information and subsequent action or inaction is solely at the user's risk, and we do not assume any responsibility for the same. The content on the Platform should not be considered or used as a substitute for professional and qualified medical advice. Please consult your doctor for any query pertaining to medicines, tests and/or diseases, as we support, and do not replace the doctor-patient relationship.

Reference

  1. Drugs.com Clinical Review Team. Flumazenil Clinical Drug Monograph. Auckland, NZ: Drugs.com; 2026. [Accessed on 02 Jun. 2026]Check here
  2. ScienceDirect Topics. Flumazenil - Research & Medical Applications Summary. Amsterdam, Netherlands: Elsevier; 2025. [Accessed on 02 Jun. 2026]Check here
  3. DrugBank Online. Db01205 Clinical & Chemical Summary. Edmonton, AB: DrugBank; 2026. [Accessed on 02 Jun. 2026]Check here
  4. Drugs.com Clinical Review Team. Flumazenil Drug Interactions Reference. Auckland, NZ: Drugs.com; 2026. [Accessed on 02 Jun. 2026]Check here
  5. Flumazenil 100 micrograms/ml solution for injection/infusion [Internet]. Org.uk. [Accessed on 2022 Jan 29]Check here
  6. Internet]. Accessdata.fda.gov. 2018 [Accessed on 4 December 2018]Check here
  7. Medscape Clinical Reference. Romazicon Flumazenil 343731 Dosage & Guidelines. New York, NY: WebMD; 2026. [Accessed on 02 Jun. 2026]Check here

Country of origin

INDIA

Manufacturer/Marketer address

140, Damji Samji Industrial Complex, Mahakali Caves Rd., Andheri(East), Mumbai-93.
Other Info - FLU0633

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