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

How Supplied

Dextromethorphan HBr, USP 10 mg - Guaifenesin, USP 100 mg available in 237 mL bottle.

NDC: 63629-1155-1 237 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 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

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 under 12 years	DO NOT USE

How Supplied (HOW SUPPLIED)

Dextromethorphan HBr, USP 10 mg - Guaifenesin, USP 100 mg available in 237 mL bottle.

NDC: 63629-1155-1 237 mL in a BOTTLE

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

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

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

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

[{"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALTITOL", "unii": "D65DG142WK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRISODIUM CITRATE DIHYDRATE", "unii": "B22547B95K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves cough due to minor throat and bronchial irritation helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive", "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 under 12 years DO NOT USE", "HOW SUPPLIED": "Dextromethorphan HBr, USP 10 mg - Guaifenesin, USP 100 mg available in 237 mL bottle. NDC: 63629-1155-1 237 mL in a BOTTLE Store at room temperature 20°-25°C (68°-77°F) Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504", "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", "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)"}