ADULT COUGH SUPPRESSANT DEXTROMETHORPHAN HBR- dextromethorphan hydrobromide capsule, liquid filled

Drug Labeling and Warnings

Drug Details [pdf]

Drug Facts

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 MAΟΙ drug. If you do not know if your prescription drug contains an MAΟΙ, 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

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.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

do not take more than 8 softgels 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 older: take 2 softgels every 6 to 8 hours, as needed
• children under 12 years: do not use

Other information

store below 25°C (77°F)
avoid excessive heat above 40°C(104°F)
protect from light

Inactive ingredients

FD&C Blue No. 1, FD&C Red No. 40, gelatin, glycerin, polyethylene glycol 400, propyl gallate, propylene glycol, purified water, Polyvinylpyrrolidone, sorbitol sorbitan solution

Questions or comments?

Call 1-888-577-8033 Monday-Friday 8AM-4PM EST

SPL UNCLASSIFIED SECTION

compare to the active ingredient in Robitussin® CoughGels®*

relieves:
cough for up to 8 hours

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Robitussin® CoughGels®.

Distributed by:
RUGBY® LABORATORIES,
Indianapolis, IN 46268
(800) 616-2471
www.major-rugby.com

Product of India

Packaging

INGREDIENTS AND APPEARANCE

ADULT COUGH SUPPRESSANT DEXTROMETHORPHAN HBR 
dextromethorphan hydrobromide capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1480
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYL GALLATE (UNII: 8D4SNN7V92)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
POVIDONE K30 (UNII: U725QWY32X)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	14mm
Flavor		Imprint Code	T
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1480-34	20 in 1 BOTTLE; Type 0: Not a Combination Product	05/08/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	05/08/2026

Labeler - Rugby Laboratories (079246066)