GUAIASORB DM- dextromethorphan hydrobromide and guaifenesin liquid

Guaiasorb DM by

Drug Labeling and Warnings

Guaiasorb DM by is a Otc medication manufactured, distributed, or labeled by Geri-Care Pharmaceuticals, Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients (in each 5 mL teaspoonful)

Dextromethorphan HBr 10 mg

Guaifenesin 100 mg

Purpose

Expectorant
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

Inactive ingredients

citric acid, flavor, glycerin, menthol, sodium saccharin, sodium benzoate, sorbitol, water

Other information

• store at room temperature between 15°-30°C (59° -86°F)
• TAMPER EVIDENT: Do not use this product if breakaway band on cap is broken or missing

SPL UNCLASSIFIED SECTION

Distributed by:

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GUAIASORB DM 
dextromethorphan hydrobromide and guaifenesin liquid

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57896-756-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/01/2015	09/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/05/1995	09/30/2020

Labeler - Geri-Care Pharmaceuticals, Corp (611196254)

Registrant - Geri-Care Pharmaceuticals, Corp (611196254)