Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

TUSSIN SUGAR FREE COUGH- dextromethorphan hydrobromide, guaifenesin liquid 
Major Pharmaceuticals

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

Dextromethorphan HBr,USP 10 mg
Guaifenesin, USP 100 mg

Purpose

Dextromethorphan HBr...................Cough suppressant
Guaifenesin, USP..............................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 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

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

When using this product

do not use more than directed

Stop use and ask a doctor if

cough 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 health
professional before use.

Keep this and all drugs out of the reach of children.

In case of accidental overdose, seek professional
assistance or contact a Poison Control Center
immediately.

Directions

do not exceed 6 doses in a 24-hour period
this adult product is not intended for use in
children under 12 years of age

Age                                                                Dose
adults and children 12 years and over     2 teaspoonfuls (tsps) every 4 hours
children under 12 years                              do not use

Other Information

store at controlled room temperature

alcohol-free

sugar-free

dosage cup provided

Inactive Ingredients

acesulfame potassium, citric acid, flavors,
glycerin, methyl paraben, polyethylene glycol,
povidone, propylene glycol, purified water,
saccharin sodium, sodium benzoate

Principal Display Panel

TUSSIN SUGAR FREE COUGH 
dextromethorphan hydrobromide, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-5180
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
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY (Cherry)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-5180-09	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/07/2009	06/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	01/07/2009	06/01/2019

Labeler - Major Pharmaceuticals (191427277)

Revised: 6/2017

Document Id: 6e32a54e-da29-47b1-b0fd-c0828aadb9a2

34390-5

Set id: 87aec0cd-a35d-4a6c-bde0-f8fd3a5ae1f7

Version: 2

Effective Time: 20170613