GUIATUSS DM - dextromethorphan hydrobromide and guaifenesin syrup
Goldline Laboratories, Inc.

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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Drug Facts

Active ingredients (in each teaspoonful (5 mL))	Purposes
Dextromethorphan HBr USP 10 mg	Cough suppressant
Guaifenesin USP 100 mg	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 use

in a child under 12 years
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 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 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 right away.

Directions

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

adults and children 12 years and over	2 teaspoonfuls every 4 hours or as directed by a doctor
children under 12 years	do not use

Other information

each teaspoonful (5 mL) contains: sodium 3 mg
store at room temperature 15°-30°C (59°-86°F)

Inactive ingredients

artificial cherry flavor, citric acid, corn syrup, FD&C red #40, glycerin, menthol, purified water, sodium benzoate, sodium saccharin

Questions?

call 1-888-838-2872, weekdays, 8 AM - 5 PM Eastern Time

GUIATUSS DM
dextromethorphan hydrobromide and guaifenesin syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0182-6064
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
CITRIC ACID MONOHYDRATE
CORN SYRUP
FD&C RED NO. 40
GLYCERIN
MENTHOL
WATER
SODIUM BENZOATE
SACCHARIN SODIUM DIHYDRATE

Product Characteristics
Color	RED (reddish-pink)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:0182-6064-40	473 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	09/01/1984	09/30/2011

Labeler - Goldline Laboratories, Inc. (032349292)

Revised: 09/2012 Goldline Laboratories, Inc.