ADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY- dextromethorphan hydrobromide and guaifenesin liquid 
Safeway, 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.

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Drug Facts

Active ingredients (in each 5 mL, 1 teaspoon)

Dextromethorphan HBr 10 mg

Guaifenesin 100 mg

Purposes

Cough suppressant

Expectorant

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

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)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

When using this product,

do not use more than directed.

Stop use and ask a doctor if

cough lasts 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.

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

Directions

  • do not take more than 6 doses in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age
  • measure only with dosing cup provided
  • keep dosing cup with product
  • tsp = teaspoon, mL = milliliter
 age dose
 adults and children 12 years and over 2 tsp (10 mL) every 4 hours
 children under 12 years do not use

Other information

  • store at 20°-25°C (68°-77°F). Do not refrigerate.

Inactive ingredients

citric acid, FD&C red #40, glucose, glycerin, high fructose corn syrup, menthol, natural & artifical flavor, purified water, saccharin sodium, sodium benzoate

Principal Display Panel

Non-Drowsy Adult Cough & Chest Congestion Relief DM

Dextromethorphan HBr 10 mg

-Cough Suppressant

Guaifenesin 100 mg

-Expectorant

Original Flavor

Compare to Robitussin® Peek Cold Cough & Chest Congestion DM active ingredients*

  • Relief of: Cough, chest congestion
  • For ages 12 & over
  • Alcohol free
  • Dosing cup included

*This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Robitussin® Peak Cold Cough & Chest Congestion DM.

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

DISTRIBUTED BY SAFEWAY INC.

P.O BOX 99, PLEASANTON, CA 94566-0009

1-888-SAFEWAY

www.safeway.com

Package Label

Dextromethorphan HBr 10 mg, Guaifenesin 100 mg

Safeway Non Drowsy Adult COugh and Chest Congestion Relief DM

ADULT COUGH AND CHEST CONGESTION RELIEF DM  NON DROWSY
dextromethorphan hbr, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:21130-385
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
GLYCERIN 
WATER 
SACCHARIN SODIUM 
SODIUM BENZOATE 
FD&C RED NO. 40 
DEXTROSE 
HIGH FRUCTOSE CORN SYRUP 
MENTHOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-385-041 in 1 BOX
1118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/30/2014
Labeler - Safeway, Inc. (009137209)

Revised: 7/2014
Document Id: e94f3686-fc81-4368-bc28-0654a09cd1f0
Set id: 5bd508a0-2f75-413e-a690-bed970131bef
Version: 1
Effective Time: 20140728
 
Safeway, Inc.