GUAIFENESIN DM- dextromethorphan hydrobromide,guaifenesin liquid

Guaifenesin DM by

Drug Labeling and Warnings

Guaifenesin DM by is a Otc medication manufactured, distributed, or labeled by Innovida Pharmaeutique Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each 5mL 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 useif 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 ifcough 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 healthcare professional before use.
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

KEEP OUT OF REACH OF CHILDREN

Directions

do not take more than 6 doses in any 24 hour period

• Adults and Children 12 years of age and over: 10mL (2 teaspoonfuls every 4 hours or as directed by doctor)
• Children under 12 years of age: Do not use

Other Information

• store at room temperature
• 15° to 30°C (59° to 86°F) TAMPER-EVIDENT;
• do not use if seal under cap is torn broken or missing.

Inactive Ingredients

CITRIC ACID, FD&C RED NO. 40, GLYCERIN, GLYCERIN, METHYLPARABEN, POTASSIUM SORBATE, PROPYLENE GLYCOL, PROPYLPARABEN, WATER, SODIUM CITRATE, Strawberry Flavor, SUCRALOSE

Questions or Comments? 1-888-462-4166

Product label

INGREDIENTS AND APPEARANCE

GUAIFENESIN DM 
dextromethorphan hydrobromide,guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71800-057
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
CITRIC ACID (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)
STRAWBERRY (UNII: 4J2TY8Y81V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71800-057-05	119 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/20/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	03/20/2025

Labeler - Innovida Pharmaeutique Corporation (080892908)