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Tussin Sugar Free Cough by Major Pharmaceuticals

Medically reviewed on June 13, 2017

Dosage form: liquid
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 10mg in 5mL, GUAIFENESIN 100mg in 5mL
Labeler: Major Pharmaceuticals
NDC Code: 0904-5180

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.

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5180
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
CITRIC ACID MONOHYDRATE 
GLYCERIN 
METHYLPARABEN 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POVIDONE 
PROPYLENE GLYCOL 
SACCHARIN SODIUM 
SODIUM BENZOATE 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (Cherry) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-5180-09237 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34101/07/200906/01/2019
Labeler - Major Pharmaceuticals (191427277)

 
Major Pharmaceuticals

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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