guaifenesin and dextromethorphan hydrobromide syrup

guaifenesin and dextromethorphan hydrobromide syrup
SPL v9
SPL
SPL Set ID 389230e5-775e-5b0d-e054-00144ff88e88
Route
oral
Published
Effective Date 2016-06-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

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

Purpose

Cough suppressant Expectorant

Description

Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 100 mg


Medication Information

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.

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

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)
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

Description

Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 100 mg

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

Questions

1-877-250-3427

Active Ingredients

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg

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

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.

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

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)
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

Questions

1-877-250-3427

Active Ingredients (Active ingredients)

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg

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


Raw Label Data

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