Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (18 mg) Guaifenesin (200 mg) Phenylephrine (10 mg)

Inactive Ingredients

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

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2018-03-15

Medication Information

Description

Drug Facts

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help you get to sleep
- nasal congestion due to a cold

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50567-7

When using this product do not use more than directed

Section 50570-1

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.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Active ingredients (in each 15 mL (TBSP)	Purpose
Dextromethorphan HBr 18 mg	Cough Suppressant
Guaifenesin 200 mg	Expectorant
Phenylephrine HCl 10 mg	Nasal Decongestant

Directions

do not take more than 6 doses in any 24-hour period
use enclosed dosage cup or tablespoon (TBSP)
dose as follows or as directed by a doctor

Adults and children 12 years of age and over:	15 mL (1 TBSP) every 4 hours, not to exceed 90 mL (6 TBSP) in a 24 hour period
Children 6 to under 12 years of age:	7.5 mL (1/2 TBSP) every 4 hours, not to exceed 45 mL (3 TBSP) in a 24 hour period.
Children under 6 years of age:	Consult a doctor.

Other Information

Each 15 mL (TBSP) contains Sodium 8 mg.
store at 68°-86°F (20°-30°C)

Inactive Ingredients

citric acid anhydrous, glycerin, propylene glycol, purified water, raspberry flavor, sodium benzoate, sodium citrate dihydrate, sodium saccharin, sorbitol.

Questions Or Comments?

Call weekdays from 9 AM to 5 PM EST at 1-844-7294. You may also report serious side effects to this phone number.

Stop Use and Ask A Doctor If

nervousness, dizziness or sleeplessness occurs
symptoms do not improve within 7 days or are accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
new symptoms occur

Ask A Doctor Before Use If You Have

heart disease
high blood pressure
thyroid disease
diabetes
a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
a cough that occurs with too much phlegm (mucus)
difficulty in urination due to enlargement of the prostate gland

Principal Display Panel 240 Ml Bottle Label

NDC 69367-184-08

Cough

Cold/Congestion

Dextromethorphan HBr

Guaifenesin

Phenylephrine HCl

Each 15 mL (TBSP) contains:

Dextromethorphan HBr

18 mg

Guaifenesin

200 mg

Phenylephrine HCl

10 mg

Cough Suppressant ∙ Expectorant ∙ Nasal Decongestant

Raspberry Flavor

Alcohol Free / Sugar Free

Gluten Free / Dye Free

8 fl. oz. (240 mL)

Westminster

Pharmaceuticals

Structured Label Content

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help you get to sleep
- nasal congestion due to a cold

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

When using this product do not use more than directed

Section 50570-1 (50570-1)

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.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Active ingredients (in each 15 mL (TBSP)	Purpose
Dextromethorphan HBr 18 mg	Cough Suppressant
Guaifenesin 200 mg	Expectorant
Phenylephrine HCl 10 mg	Nasal Decongestant

Directions

do not take more than 6 doses in any 24-hour period
use enclosed dosage cup or tablespoon (TBSP)
dose as follows or as directed by a doctor

Adults and children 12 years of age and over:	15 mL (1 TBSP) every 4 hours, not to exceed 90 mL (6 TBSP) in a 24 hour period
Children 6 to under 12 years of age:	7.5 mL (1/2 TBSP) every 4 hours, not to exceed 45 mL (3 TBSP) in a 24 hour period.
Children under 6 years of age:	Consult a doctor.

Other Information (Other information)

Each 15 mL (TBSP) contains Sodium 8 mg.
store at 68°-86°F (20°-30°C)

Inactive Ingredients (Inactive ingredients)

citric acid anhydrous, glycerin, propylene glycol, purified water, raspberry flavor, sodium benzoate, sodium citrate dihydrate, sodium saccharin, sorbitol.

Questions Or Comments? (Questions or Comments?)

Call weekdays from 9 AM to 5 PM EST at 1-844-7294. You may also report serious side effects to this phone number.

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

nervousness, dizziness or sleeplessness occurs
symptoms do not improve within 7 days or are accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
new symptoms occur

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

heart disease
high blood pressure
thyroid disease
diabetes
a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
a cough that occurs with too much phlegm (mucus)
difficulty in urination due to enlargement of the prostate gland

Principal Display Panel 240 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 240 mL Bottle Label)

NDC 69367-184-08

Cough

Cold/Congestion

Dextromethorphan HBr

Guaifenesin

Phenylephrine HCl

Each 15 mL (TBSP) contains:

Dextromethorphan HBr

18 mg

Guaifenesin

200 mg

Phenylephrine HCl

10 mg

Cough Suppressant ∙ Expectorant ∙ Nasal Decongestant

Raspberry Flavor

Alcohol Free / Sugar Free

Gluten Free / Dye Free

8 fl. oz. (240 mL)

Westminster

Pharmaceuticals

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep nasal congestion due to a cold", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50567-7": "When using this product do not use more than directed", "50570-1": "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.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Active ingredients (in each 15 mL (TBSP) Purpose Dextromethorphan HBr 18 mg Cough Suppressant Guaifenesin 200 mg Expectorant Phenylephrine HCl 10 mg Nasal Decongestant", "Directions": "do not take more than 6 doses in any 24-hour period use enclosed dosage cup or tablespoon (TBSP) dose as follows or as directed by a doctor Adults and children 12 years of age and over: 15 mL (1 TBSP) every 4 hours, not to exceed 90 mL (6 TBSP) in a 24 hour period Children 6 to under 12 years of age: 7.5 mL (1/2 TBSP) every 4 hours, not to exceed 45 mL (3 TBSP) in a 24 hour period. Children under 6 years of age: Consult a doctor.", "Other information": "Each 15 mL (TBSP) contains Sodium 8 mg. store at 68°-86°F (20°-30°C)", "Inactive ingredients": "citric acid anhydrous, glycerin, propylene glycol, purified water, raspberry flavor, sodium benzoate, sodium citrate dihydrate, sodium saccharin, sorbitol.", "Questions or Comments?": "Call weekdays from 9 AM to 5 PM EST at 1-844-7294. You may also report serious side effects to this phone number.", "Stop use and ask a doctor if": "nervousness, dizziness or sleeplessness occurs symptoms do not improve within 7 days or are accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition. new symptoms occur", "Ask a doctor before use if you have": "heart disease high blood pressure thyroid disease diabetes a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema a cough that occurs with too much phlegm (mucus) difficulty in urination due to enlargement of the prostate gland", "PRINCIPAL DISPLAY PANEL - 240 mL Bottle Label": "NDC 69367-184-08 Cough Cold/Congestion Dextromethorphan HBr Guaifenesin Phenylephrine HCl Each 15 mL (TBSP) contains: Dextromethorphan HBr 18 mg Guaifenesin 200 mg Phenylephrine HCl 10 mg Cough Suppressant ∙ Expectorant ∙ Nasal Decongestant Raspberry Flavor Alcohol Free / Sugar Free Gluten Free / Dye Free 8 fl. oz. (240 mL) Westminster Pharmaceuticals"}

Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information