Guaifenesin And Dextromethorphan Hydrobromide Syrup

Guaifenesin And Dextromethorphan Hydrobromide Syrup
SPL v1
SPL
SPL Set ID 9a77465c-6d3a-4399-9734-ad22e4b435db
Route
ORAL
Published
Effective Date 2024-04-22
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, Unspecified Form Sodium Benzoate Dextrose, Unspecified Form Anhydrous Citric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-01

Description

Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 100 mg

Purpose

Cough suppressant Expectorant

How Supplied

Dextromethorphan HBr, USP 10 mg - Guaifenesin, USP 100 mg. NDC 72162-2277-2: 237 mL in a Bottle. Store at room temperature 20°-25°C (68°-77°F) Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504


Medication Information

Purpose

Cough suppressant

Expectorant

How Supplied

Dextromethorphan HBr, USP 10 mg - Guaifenesin, USP 100 mg.

  • NDC 72162-2277-2: 237 mL in a Bottle.

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

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

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
Section 51945-4

Guaifenesin and Dextromethorphan Hydrobromide Syrup 100 mg/10 mg/5 mL

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

Tamper Evident

Do not use if seal cap is broken or missing.

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

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg

Inactive Ingredients

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

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
Section 51945-4 (51945-4)

Guaifenesin and Dextromethorphan Hydrobromide Syrup 100 mg/10 mg/5 mL

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

How Supplied (HOW SUPPLIED)

Dextromethorphan HBr, USP 10 mg - Guaifenesin, USP 100 mg.

  • NDC 72162-2277-2: 237 mL in a Bottle.

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

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Tamper Evident (TAMPER-EVIDENT)

Do not use if seal cap is broken or missing.

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

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 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

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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