COUGH RELIEF- dextromethorphan hbr capsule, liquid filled

Cough Relief by

Drug Labeling and Warnings

Cough Relief by is a Otc medication manufactured, distributed, or labeled by ASSURED / DOLLAR TREE (Greenbrier International, Inc.). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

Dextromethorphan HBr, USP 15 mg

Purpose

Cough suppressant

Uses

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.

Ask a doctor before use if you have

• cough that occurs with too much phlegm (mucus)
• a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

Stop use and ask a doctor if

cough lasts more than 7 days, comes back, or is accompanied by fever, rash or headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep this and all drugs out of the reach of children.

In case of overdose, seek medical help or contact a Poison Control Center right away. (1-800-222-1222)

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 over: take 2 softgels every 6 to 8 hours, as needed
• children under 12 years of age: do not use

Other information

• store between 20-25ºC (68-77ºF)
• avoid excessive heat above 40ºC (104ºF); protect from light

Inactive ingredients

FD&C red 40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

Questions or comments?

Call 1-877-753-33935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO ACTIVE INGREDIENT OF ROBITUSSIN® LONG-ACTING COUGHGELS®*

ADULT LONG LASTING

Cough Relief

Dextromethorphan HBr, 15 mg

Cough Suppressant

Relieves cough for up to 8 hours, Non-Drowsy

AGES 12+

Softgels

This product is not manufactured or distributed by Pfizer Consumer Healthcare, Distributor of Robitussin® Long-Acting CoughGels®.

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

DISTRIBUTED BY

GREENBRIER INTERNATIONAL, INC.

500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

Package Label

ASSURED Cough Relief Softgels

INGREDIENTS AND APPEARANCE

COUGH RELIEF 
dextromethorphan hbr capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 33992-0666
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 RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	RED	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	404
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 33992-0666-5	1 in 1 BOX	06/30/2017
1		15 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	06/30/2017

Labeler - ASSURED / DOLLAR TREE (Greenbrier International, Inc.) (610322518)