COUGH SYRUP- dextromethorphan hydrobromide and guaifenesin liquid
Meijer Distribution 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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Meijer Distribution, Inc. Cough Syrup Drug Facts

Active ingredient (in each 5 mL tsp)

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg

Purpose

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 drain bronchial tubes

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

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. A persistent cough may be a sign 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 right away. (1-800-222-1222)

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

age	dose
adults and children 12 years and over	2 teaspoons every 4 hours
children under 12 years	do not use

Other information

Phenylketonurics: contains phenylalanine 15 mg per teaspoon
store at 20°-25°C (68°-77°F)

Inactive ingredients

aspartame, benzoic acid, flavor, glycerin, hydroxyethyl cellulose, polyethylene glycol, purified water

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Robitussin® Cough & Chest Congestion DM active ingredients

Adult

For Ages 12 & Over

Non-Drowsy

Sugar Free Tussin

Cough Syrup

Cough Suppressant (dextromethorphan HBr)

Expectorant (guaifenesin)

Specially Formulated for Diabetics

Relieves:

Coughs

Chest Congestion

Mucus

Alcohol & Sugar Free

Cough Syrup Carton Image 1

Cough Syrup Carton Image 2

COUGH SYRUP
dextromethorphan hbr, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:41250-578
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg in 5 mL
GUAIFENESIN (GUAIFENESIN)	GUAIFENESIN	100 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
ASPARTAME
BENZOIC ACID
GLYCERIN
MENTHOL
POLYETHYLENE GLYCOLS
WATER
MENTHOL

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:41250-578-26	1 in 1 CARTON
1		118 mL in 1 BOTTLE
2	NDC:41250-578-34	1 in 1 CARTON
2		237 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	10/07/1994

Labeler - Meijer Distribution Inc (006959555)

Revised: 12/2011

Document Id: 91046e1d-b7a1-4460-a7ee-de09e30da6bd

Set id: abc9e0b9-008b-496d-b0fe-4c192472533e

Version: 2

Effective Time: 20111211

Meijer Distribution Inc