Otc - Active Ingredient
Active ingredient (in each liquid-filled capsule)
Dextromethorphan HBr, USP 15 mg
Robitussin Direct Cough Capsule, Liquid Filled
FDA Label NDC 0031-9302
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Robitussin Direct Cough (NDC 0031-9302). 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, ask a doctor before use if you have, 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.
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
adults and children 12 years and over | take 1 capsule (15 mg) every 4 hours, as required |
children under 12 years | do not use |
Storage And Handling
Other information
- store at 20°C-25°C (68°F -77°F)
- avoid excessive heat above 40°C (104°F)
- protect from light
Inactive Ingredient
Inactive ingredients
FD&C blue no. 1, FD&C red no. 40, fractionated coconut oil, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propyl gallate, propylene glycol, purified water, sorbitol, sorbitol anhydrides
Otc - Questions
Questions or comments?
Call weekdays from 9 AM-5 PM EST at 1-800-245-1040
Additional Information
Do not use if safety seal under cap printed with “Sealed for Your Protection” is broken or missing.
Should be 18 or older to purchase
PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org
Lift Here for More Drug Facts
Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
visit www.robitussin.com
Trademarks owned or licensed by GSK.
©2022 GSK or licensor.
Made in India
Principal Display Panel
NEW
Robitussin
Cough
Dextromethorphan HBr
(Cough Suppressant)
direct
Actual size
18
Liqui-Gels®*
*Liquid filled capsules
L-0630-782-44-UPC_ORG Front Label
Robitussin Direct Cough 18 Liqui Gels (Image 01)
* Please review the disclaimer below.
