GUAIFENESIN DM STRAWBERRY FLAVOR- guaifenesin, dextromethorphan hydrobromide liquid

Drug Labeling and Warnings

Drug Details [pdf]

Active ingredient in each 5 mL in one teaspoonful)           Purpose

Dextromethorphan HBr USP 10 mg...............Cough suppressant

Guaifenesin USP 100 mg.........................................Expectorant

PURPOSE

Uses

• temporarily quiets cough associated with the common cold or inhaled irritants, 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 you are taking a prescription drug that
contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if

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

Stop use and ask a doctor if

• cough lasts for more than 7 days, comes back, or occurs with fever, rash, or headache 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 (1-800-222-1222) right away.

KEEP OUT OF REACH OF CHILDREN

Directions

• Do not take more than 6 doses in any 24 hours period

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

Other Information

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

Inactive Ingredients

Citric acid, FD&C red #40, glycerin, menthol, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, sodium citrate, strawberry flavor, sucralose.

Questions or Comments? 1-888-711-7116

TAMPER EVIDENT: DO NOT USE IF SEAL UNDER CAP IS TORN, BROKEN OR MISSING.

Product label

INGREDIENTS AND APPEARANCE

GUAIFENESIN DM STRAWBERRY FLAVOR 
guaifenesin, dextromethorphan hydrobromide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71085-107
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 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: 71085-107-19	119 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/31/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	03/31/2026

Labeler - IPG PHARMACEUTICALS, INC. (080441238)