Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameDEXTROMETHORPHAN HBR
Labeler / manufacturerBIONPHARMA INC.
RouteORAL
Drug classDrug class not supplied in source label
Product NDC69452-573
Label effective date2026-08-31
Official product label reference
Dextromethorphan HBr — BIONPHARMA INC.
This page contains 13 source sections for DEXTROMETHORPHAN HBR, oral route. Label set 5a5dde85-8785-8149-e063-6294a90a4d57, version 1.
Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.
Uses described in the label
Use temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.
Purpose
Purpose Cough Suppressant
Dosage and administration — label text
Directions ■ do not take more than 8 capsules in any 24-hour period ■ this product is not intended for use in children under 12 years of age adults and children 12 years and over take 2 capsules every 6 to 8 hours, or as directed by a doctor children under 12 years do not use
Table text from source:
| adults and children 12 years and over | take 2 capsules every 6 to 8 hours, or as directed by a doctor
| children under 12 years | do not use
Warnings
Warnings 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. Ask a doctor before use if you have ■ cough that is accompanied by excessive phlegm (mucus) ■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema Stop use and ask doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. I n case of overdose, get medical help or contact a Poison Control Center right away.
Unclassified section
Drug Facts
*This product is not manufactured or distributed by the owners of Robitussin® Long-Acting CoughGels®. Tamper-Evident: Do not use if printed seal under cap is missing or damaged Manufactured for: BIONPHARMA Princeton, NJ 08540 Code:TN/Drugs/TN00003701 MADE IN INDIA PML00430 NDC 69452-573-17 L0001304 R0726
Active ingredient
Active ingredient (in each softgel) Dextromethorphan HBr USP, 15 mg
Ask a doctor before use
Ask a doctor before use if you have ■ cough that is accompanied by excessive phlegm (mucus) ■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema
When to stop use and seek help
Stop use and ask doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
Pregnancy or breast feeding
If pregnant or breast-feeding, ask a health professional before use.
Child safety
Keep out of reach of children. I n case of overdose, get medical help or contact a Poison Control Center right away.
Storage and handling
Other information ■ store at 20-25°C (68-77°F) ■ avoid excessive heat above 40°C (104°F) ■ protect from light and moisture
The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.