guaifenesin and dextromethorphan hydrobromide syrup

guaifenesin and dextromethorphan hydrobromide syrup
SPL v3
SPL
SPL Set ID 1538bf63-d020-3ba2-e063-6294a90aecc5
Route
oral
Published
Effective Date 2024-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dextromethorphan (10 mg) guaifenesin (100 mg)
Inactive Ingredients
glycerin fd&c red no. 40 saccharin sodium high fructose corn syrup menthol sodium benzoate dextrose anhydrous citric acid

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-04-01

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 6 to 12 years of age 1 teaspoonful (TSP) every 4 hours
children under 6 years DO NOT USE

Other Information
  • store at room temperature 20°-25°C (68°-77°F)
  • each 5 mL contains: sodium 3 mg
Inactive Ingredients

Anhydrous citric acid, dextrose, FD&C Red #40, flavor, gylcerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate

Description

Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 100 mg

Principal Display Panel

Method Pharmaceuticals

NDC 58657-504-08

Guaifenesin and Dextromethorphan Hydrobromide Syrup

100 mg/10 mg/5 mL

Expectorant

Cough Suppressant

Grape Flavor

Non Drowsy • Alcohol Free

FOR AGES 12 AND UP

8 fl. oz. (237 mL)

Manufactured For:

Method Pharmaceuticals, LLC

Southlake, TX 76092 Rev. 02/2024

Questions

1-877-250-3427

Tamper Evident

Do not use if seal cap is broken or missing.

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 6 to 12 years of age 1 teaspoonful (TSP) every 4 hours
children under 6 years DO NOT USE

Other Information (Other information)
  • store at room temperature 20°-25°C (68°-77°F)
  • each 5 mL contains: sodium 3 mg
Inactive Ingredients (Inactive ingredients)

Anhydrous citric acid, dextrose, FD&C Red #40, flavor, gylcerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate

Principal Display Panel

Method Pharmaceuticals

NDC 58657-504-08

Guaifenesin and Dextromethorphan Hydrobromide Syrup

100 mg/10 mg/5 mL

Expectorant

Cough Suppressant

Grape Flavor

Non Drowsy • Alcohol Free

FOR AGES 12 AND UP

8 fl. oz. (237 mL)

Manufactured For:

Method Pharmaceuticals, LLC

Southlake, TX 76092 Rev. 02/2024

Questions

1-877-250-3427

Tamper Evident (TAMPER-EVIDENT)

Do not use if seal cap is broken or missing.

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

All Sections (JSON)