Dextromethorphan Hbr Capsule, Liquid Filled
FDA Label NDC 69452-573
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bionpharma Inc. for the product Dextromethorphan Hbr (NDC 69452-573). 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 drug facts, active ingredient (in each softgel), purpose, use, warnings, 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
Active Ingredient (In Each Softgel)
Dextromethorphan HBr USP, 15 mg
Purpose
Cough Suppressant
Use
temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.
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.
Otc - Ask Doctor
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
Otc - Stop Use
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, 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.
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 |
Other Information
■ store at 20-25°C (68-77°F)
■ avoid excessive heat above 40°C (104°F)
■ protect from light and moisture
Inactive Ingredients
FD&C Blue No.1, FD&C Red No.40, gelatin, glycerin, pharmaceutical imprinting ink, polyethylene glycol 400, povidone, propylene glycol, propyl gallate, purified water, sorbitol sorbitan solution
Questions Or Comments?
call toll-free 1-888-235-2466
Other
*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
60'S Count
*compare to the active ingredient in
Robitussin® Long-Acting CoughGels®
a+ health
TM
dextromethorphan
HBr capsules, 15 mg
cough suppressant
relieves cough for
up to 8 hours
for ages 12 & over
60 SOFTGELS**
**liquid-filled
capsules
Image-01 (Image 01)
* Please review the disclaimer below.
