Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID c1288446-789a-447c-b9ef-61d4a5427b9d
Route
ORAL
Published
Effective Date 2009-11-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Guaifenesin (100 mg)
Inactive Ingredients
Acesulfame Potassium Citric Acid Monohydrate Glycerin Methylparaben Polyethylene Glycol Povidone Propylene Glycol Saccharin Sodium Sodium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2009-01-07

Description

Dextromethorphan HBr,USP 10 mg Guaifenesin, USP 100 mg

Purpose

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


Medication Information

Purpose

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

Description

Dextromethorphan HBr,USP 10 mg Guaifenesin, USP 100 mg

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.











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



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





Other Information
sugar-free dosage cup provided

• store at controlled room temperature

alcohol-free







Active Ingredients

Dextromethorphan HBr,USP 10 mg Guaifenesin, USP 100 mg



Inactive Ingredients

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





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.

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





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.



Tussin Sugar Free Cough (dextromethorphan Hydrobromide, Guaifenesin) Liquid

Structured Label Content

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





Purpose

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

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.











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



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





Other Information
sugar-free dosage cup provided

• store at controlled room temperature

alcohol-free







Active Ingredients

Dextromethorphan HBr,USP 10 mg Guaifenesin, USP 100 mg



Inactive Ingredients

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





When Using This Product (When using this product)

• do not use more than directed

Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Ask A Doctor Before Use If You Have (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





Keep This and All Drugs Out of the Reach of Children. (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.



Tussin Sugar Free Cough (dextromethorphan Hydrobromide, Guaifenesin) Liquid (TUSSIN SUGAR FREE COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID)

Advanced Ingredient Data


Raw Label Data

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