Otc - Active Ingredient
Active ingredient (in each soft gelatin capsule)
Dextromethorphan HBr, USP 15 mg
Dextromethorphan Hydrobromide Capsule, Liquid Filled
FDA Label NDC 35916-0461
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Softgel Healthcare Pvt Ltd for the product Dextromethorphan Hydrobromide (NDC 35916-0461). 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 - Purpose
Purpose
Cough suppressant
Indications & Usage
Use
temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.
Warnings
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 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.
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 20-25°C (68-77°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, sorbital sorbitan solution, water
Other
Do Not Use if foil is torn or missing.
Manufactured By
Softgel Healthcare Pvt. Ltd.,
Survey No. 20/1, Vandalur-Kelambakkam Road,
Pudupakkam Village, Kancheepuram District,
Tamilnadu - 603 103, India.
Mfg. Lic. No.:XXXXXXXXXXXX
Principal Display Panel
ADULT
NDC 35916-0461-1
*Compared to the active ingredientsin Robitussin ® Long-Acting CoughGels ®
Dextromethorphan Hydrobromide Capsules, 15mg
(Cough Suppressant)
20 Softgels
Liquid Filled Capsules
Upto
8
hour
relief
Non-Drowsy Formula
For Ages 12 & Over
* Please review the disclaimer below.
