Guaifenesin And Dextromethorphan Hydrobromide Syrup

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (10 mg) Guaifenesin (100 mg)

Inactive Ingredients

Glycerin Maltitol Saccharin Sodium Propylene Glycol Anhydrous Citric Acid Trisodium Citrate Dihydrate Sorbitol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2016-06-14

Medication Information

Purpose

Cough suppressant

Expectorant

Description

Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 100 mg

Uses

temporarily relieves cough due to minor throat and bronchial

irritation
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.

Questions

1-877-250-3427

Directions

do not take more than 6 doses in any 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 (TSP) every 4 hours
children under 12 years	DO NOT USE

Other Information

store at room temperature 20°-25°C (68°-77°F)

Active Ingredients

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg

Inactive Ingredients

Citric Acid Anhydrous, USP; Sodium Citrate Dihydrate, USP; Sodium Saccharin, USP; Propylene Glycol, USP; Grape Flavor; Sorbitol Solution, USP; Glycerin, USP; Maltitol Solution, NF

Principal Display Panel

Method Pharmaceuticals

NDC 58657-505-08

Guaifenesin and Dextromethorphan Hydrobromide Syrup

100 mg/10 mg/5 mL

Expectorant

Cough Suppressant

Grap Flavor

Non Drowsy • Alcohol Free

FOR AGES 12 AND UP

8 fl. oz. (237 mL)

Manufactured For:

Method Pharmaceuticals, LLC

Fort Worth, TX 76118 Rev. 06/2016

Stop Use and Ask A Doctor If

cough lasts more than 7 days or occurs with fever, rash, or

headaches that lasts. This could be a sign of a serious condition
hypersensitive to any ingredients

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.

Ask A Doctor Before Use If You Have

persistent cough or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema
cough accompanied by excessive phlegm (mucus)

Structured Label Content

Uses

temporarily relieves cough due to minor throat and bronchial

irritation
helps loosen phlegm (mucus) and thin bronchial secretions

to make coughs more productive

Purpose

Cough suppressant

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.

Questions

1-877-250-3427

Directions

do not take more than 6 doses in any 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 (TSP) every 4 hours
children under 12 years	DO NOT USE

Other Information (Other information)

store at room temperature 20°-25°C (68°-77°F)

Active Ingredients (Active ingredients)

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg

Inactive Ingredients (Inactive ingredients)

Citric Acid Anhydrous, USP; Sodium Citrate Dihydrate, USP; Sodium Saccharin, USP; Propylene Glycol, USP; Grape Flavor; Sorbitol Solution, USP; Glycerin, USP; Maltitol Solution, NF

Principal Display Panel

Method Pharmaceuticals

NDC 58657-505-08

Guaifenesin and Dextromethorphan Hydrobromide Syrup

100 mg/10 mg/5 mL

Expectorant

Cough Suppressant

Grap Flavor

Non Drowsy • Alcohol Free

FOR AGES 12 AND UP

8 fl. oz. (237 mL)

Manufactured For:

Method Pharmaceuticals, LLC

Fort Worth, TX 76118 Rev. 06/2016

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

cough lasts more than 7 days or occurs with fever, rash, or

headaches that lasts. This could be a sign of a serious condition
hypersensitive to any ingredients

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

persistent cough or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema
cough accompanied by excessive phlegm (mucus)

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

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Guaifenesin And Dextromethorphan Hydrobromide Syrup

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information