COUGH RELIEF- dextromethorphan hbr capsule, liquid filled 
ASSURED / DOLLAR TREE (Greenbrier International, Inc.)

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Drug Facts

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

Dextromethorphan HBr, USP 15 mg

ASSURED Cough Relief Softgels

COUGH RELIEF 
dextromethorphan hbr capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0666
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorredScoreno score
ShapeOVALSize12mm
FlavorImprint Code 404
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-0666-51 in 1 BOX06/30/201712/31/2023
115 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/30/201712/31/2023
Labeler - ASSURED / DOLLAR TREE (Greenbrier International, Inc.) (610322518)

Revised: 10/2021
Document Id: b2fc17a8-1922-4752-a52d-023afa8b5f15
Set id: aaefda09-5379-4192-af38-a04cfc789c52
Version: 5
Effective Time: 20211007
 
ASSURED / DOLLAR TREE (Greenbrier International, Inc.)