DOMETUSS-DM- guaifenesin, dextromethorphan hbr liquid

DOMETUSS-DM by

Drug Labeling and Warnings

DOMETUSS-DM by is a Otc medication manufactured, distributed, or labeled by Domel Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug FactsActive ingredients (in each 5 mL tsp)

Guaifenesin 200mg

Dextromethorphan HBr 30 mg

Purpose

Expectorant

Cough suppressant

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
• temporarily relieves coughs due to minor throat and bronchial irritation as may occur with a cold.

Warnings

• Do not exceed recommended dosage.
• A persistant cough may be a sign of a serious condition; if cough persists for more than one week, tend to recur, or is accompanied by fever, rash, or persistant headache, consult a doctor.

Do not use this product

• for persistant or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor
• If you are now taking a prescription Monoaminooxidase Inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions or Parkinson's disease), or for two 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.

If pregnant or breast-feeding

as a health professional before use.

Directions

Do not exceed more than 4 doses in any 24- hour period, or as directed by a physician.

 

• Adults and children 12 years of age and over: Take 1 teaspoonful (5 mL) every 6 hours
• Children 6 to under 12 years of age: Take 1/2 teaspoonful (2.5 mL) every 6 hours
• Children under 6 years of age: Ask a doctor

 

Other Information

store at room temperature 15°-30°C (59°-86°F).

Tamper Evident: Do not use if there is evidence of tampering.

Inactive ingredients

Artificial grape flavor, citric acid, D&C red #33, FD&C blue #1, glycerin, methyl paraben (as preserative), propylene glycol, propyl paraben (as preseratie, purified water, sodium citrate, sucralose.

Questions or comments?

Please call (787) 767-3246

DOMETUSS-DM product label

NDC: 53809-201-01

DOMETUSS-DM

EXPECTORANT/COUGH SUPPRESSANT

Alcohol and Sugar

FREE

Grape Flavoe

1 Fl. Oz.

Rev: 10/13

Lot#:/EXP.DATE:

Manufactured for:

DOMEL

SAN JUAN, PUERTO RICO 00924

INGREDIENTS AND APPEARANCE

DOMETUSS-DM 
guaifenesin, dextromethorphan hbr liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53809-201
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	grape	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53809-201-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/21/2016
2	NDC: 53809-201-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/21/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/21/2016

Labeler - Domel Laboratories (808198837)

Registrant - Domel Laboratories (808198837)