Dextromethorphan Hydrobromide Capsule, Liquid Filled
FDA Label NDC 72657-484

13 label sections · Submitted to the FDA by Glenmark Therapeutics Inc., Usa · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Glenmark Therapeutics Inc., Usa for the product Dextromethorphan Hydrobromide (NDC 72657-484). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Active Ingredient

→ Otc - Purpose

→ Indications & Usage

→ Warnings

→ Otc - Do Not Use

→ Otc - Ask Doctor

→ Otc - Stop Use

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Dosage & Administration

→ Other Safety Information

→ Inactive Ingredient

→ Principal Display Panel

Otc - Active Ingredient

Active ingredient (in each soft gelatin capsule)

Dextromethorphan HBr, USP 15 mg

Otc - Purpose

Purpose

Cough suppressant

Indications & Usage

Use

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

Warnings

Otc - Do Not Use

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Otc - Ask Doctor

Ask a doctor before use if you have

a cough that occurs with too much phlegm (mucus)
a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema

Otc - Stop Use

Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions

do not take more than 8 capsules in any 24-hour period
this adult product is not intended for use in children under 12 years of age

age	dose
adults and children 12 years and over	take 2 capsules every 6 to 8 hours, as needed
children under 12 years	do not use

Other Safety Information

Other information

store at 20 to 25°C (68 to 77°F)
avoid excessive heat above 40°C (104°F)
protect from light

Inactive Ingredient

Inactive ingredients

FD & C Red no. 40, gelatin, glycerin, polyethylene glycol 400, povidone K 30, propyl gallate, propylene glycol, purified water, sorbitol sorbitan solution

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