GUAIASORB DM - dextromethorphan hydrobromide and guaifenesin liquid
Geri-Care Pharmaceuticals, Corp

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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Active Ingredients

Guaifenesin (100 mg in each teaspoonful (5 mL))

Dextromethorphan HBr (10 mg in each teaspoonful (5 mL))

Purpose

Guaifenesin .................................. Expectorant
Dextromethorphan HBr .....................Cough Suppressant

Uses

temporarily relieves cough due to minor throat and bronchial irritation
helps loosen phlegm (mucus)
helps 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

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

Stop use and ask a doctor if

cough lasts more than 7 days, comes back, or accompanied by fever, rash, or headaches that lasts. 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 right away.

Directions

take every 4 hours as needed, or as directed by a doctor
do not take more than 6 doses in 24 hours
do not exceed recommended dose

Adult and children 12 years and over	2 teaspoonfuls (10 mL)
Children under 12 years	Do not use

Other information

store at room temperature between 20°-25°C (68°-77°F)

Tamper Evident:

DO NOT USE IF IMPRINTED SAFETY NECK BAND IS BROKEN OR MISSING.

Inactive ingredients

citric acid, strawberry flavor, glycerin, menthol, methylparaben, propylene glycol, saccharin sodium, sodium benzoate, sorbitol, water.

Distributed by:

GERI-CARE PHARMACEUTICALS CORP.
1650 63rd Street
Brooklyn, NY 11204 USA

Container Label

GUAIASORB DM
dextromethorphan hydrobromide and guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57896-756
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dextromethorphan Hydrobromide (Dextromethorphan)	Dextromethorphan Hydrobromide	10 mg in 5 mL
Guaifenesin (Guaifenesin)	Guaifenesin	100 mg in 5 mL

Inactive Ingredients
Ingredient Name	Strength
anhydrous citric acid
glycerin
menthol
methylparaben
propylene glycol
saccharin sodium
sodium benzoate
sorbitol
water

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY (Strawberry flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:57896-756-04	118 mL in 1 BOTTLE, PLASTIC	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/05/1995

Labeler - Geri-Care Pharmaceuticals, Corp (611196254)

Revised: 06/2011 Geri-Care Pharmaceuticals, Corp