Drug Facts

Drug Facts

SPL v11

SPL

SPL Set ID fcd0a8e0-ac2a-039a-be3c-534195d6bcfd

Route

ORAL

Published

Effective Date 2022-06-08

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Dextromethorphan (5 mg) Guaifenesin (50 mg) Phenylephrine (2.5 mg)

Inactive Ingredients

Anhydrous Citric Acid Fd&c Red No. 40 Glycerin Propylene Glycol, (r)- Water Sodium Benzoate Sodium Citrate, Unspecified Form Sorbitol Sucralose

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

OTC MONOGRAPH DRUG Active Since 2009-09-01

Description

Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 100 mg Phenylephrine HCl, USP 5 mg

Purpose

Cough suppressant Expectorant Nasal decongestant

Medication Information

Purpose

Cough suppressant Expectorant Nasal decongestant

Description

Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 100 mg Phenylephrine HCl, USP 5 mg

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
temporarily relieves these symptoms occurring with a cold:
nasal congestion
cough due to minor throat and bronchial irritation

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 50568-5

Ask a doctor or pharmacist before use if you aretaking any other oral nasal decongestant or stimulant.

Section 50570-1

Do not useif 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.

Purposes

Cough suppressant

Expectorant

Nasal decongestant

Directions

measure only with dosing cup provided
keep dosing cup with product
mL = milliliter
do not take more than 6 doses in any 24-hour period

age	dose
children under 4 years	do not use
children 4 to under 6 years	5 mL every 4 hours
children 6 to under 12 years	10 mL every 4 hours
adults and children 12 years and over	20 mL every 4 hours

Other Information

each 10 mL contains:sodium 7 mg
store at 20-25°C (68-77°F). Do not refrigerate.

Inactive Ingredients

anhydrous citric acid, artificial flavor, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Additional Information

Packaged with Tamper-Evident bottle cap. Do Not Use

if breakable ring is separated or missing.

Children’s

Robitussin liquid

is specially

Children’s Robitussin liquid is especially formulated to provide soothing action, control your child’s cough plus relieve other cold symptoms.

Should be 18 or older to purchase

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Distributed by: GSK Consumer Healthcare,

Warren, NJ 07059

For most recent product information,

visit www.robitussin.com

Trademarks owned or licensed by GSK.

Made in Canada

Questions Or Comments?

call weekdays from 9 AM to 5 PM EST at 1-800-245-1040

Principal Display Panel

Children's

Robitussin

FOR AGES 4 & OVER

Cough & Cold

DEXTROMETHORPHAN HBr

(Cough Suppressant)

GUAIFENESIN (Expectorant)

PHENYLEPHRINE HCl (Nasal Decongestant)

Relieves:

Cough
Chest Congestion/Mucus
Stuffy Nose

Non-Drowsy

grape

flavor

4 FL OZ

(118 mL)

PAA172104 Front Carton

Stop Use and Ask A Doctor If

you get nervous, dizzy, or sleepless
symptoms do not get better within 7 days or are accompanied by fever
cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Active Ingredients (in Each 10 Ml)

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg

Phenylephrine HCl, USP 5 mg

Ask A Doctor Before Use If You Have

heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland
cough that occurs with too much phlegm (mucus)
cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

Structured Label Content

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
temporarily relieves these symptoms occurring with a cold:
nasal congestion
cough due to minor throat and bronchial irritation

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 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you aretaking any other oral nasal decongestant or stimulant.

Section 50570-1 (50570-1)

Section 53414-9 (53414-9)

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

Purposes

Cough suppressant

Expectorant

Nasal decongestant

Directions

measure only with dosing cup provided
keep dosing cup with product
mL = milliliter
do not take more than 6 doses in any 24-hour period

age	dose
children under 4 years	do not use
children 4 to under 6 years	5 mL every 4 hours
children 6 to under 12 years	10 mL every 4 hours
adults and children 12 years and over	20 mL every 4 hours

Other Information (Other information)

each 10 mL contains:sodium 7 mg
store at 20-25°C (68-77°F). Do not refrigerate.

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, artificial flavor, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Additional Information

Packaged with Tamper-Evident bottle cap. Do Not Use

if breakable ring is separated or missing.

Children’s

Robitussin liquid

is specially

Children’s Robitussin liquid is especially formulated to provide soothing action, control your child’s cough plus relieve other cold symptoms.

Should be 18 or older to purchase

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Distributed by: GSK Consumer Healthcare,

Warren, NJ 07059

For most recent product information,

visit www.robitussin.com

Trademarks owned or licensed by GSK.

Made in Canada

Questions Or Comments? (Questions or comments?)

call weekdays from 9 AM to 5 PM EST at 1-800-245-1040

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Children's

Robitussin

FOR AGES 4 & OVER

Cough & Cold

DEXTROMETHORPHAN HBr

(Cough Suppressant)

GUAIFENESIN (Expectorant)

PHENYLEPHRINE HCl (Nasal Decongestant)

Relieves:

Cough
Chest Congestion/Mucus
Stuffy Nose

Non-Drowsy

grape

flavor

4 FL OZ

(118 mL)

PAA172104 Front Carton

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

you get nervous, dizzy, or sleepless
symptoms do not get better within 7 days or are accompanied by fever
cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Active Ingredients (in Each 10 Ml) (Active ingredients (in each 10 mL))

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg

Phenylephrine HCl, USP 5 mg

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

heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland
cough that occurs with too much phlegm (mucus)
cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

Advanced Ingredient Data

[{"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL, (R)-", "unii": "602HN5L69H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE, UNSPECIFIED FORM", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "2.5", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes temporarily relieves these symptoms occurring with a cold: nasal congestion cough due to minor throat and bronchial irritation", "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.", "50568-5": "Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant.", "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.", "Purposes": "Cough suppressant Expectorant Nasal decongestant", "Directions": "measure only with dosing cup provided keep dosing cup with product mL = milliliter do not take more than 6 doses in any 24-hour period age dose children under 4 years do not use children 4 to under 6 years 5 mL every 4 hours children 6 to under 12 years 10 mL every 4 hours adults and children 12 years and over 20 mL every 4 hours", "Other information": "each 10 mL contains: sodium 7 mg store at 20-25°C (68-77°F). Do not refrigerate.", "Inactive ingredients": "anhydrous citric acid, artificial flavor, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose", "Additional Information": "Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing. Children’s Robitussin liquid is specially Children’s Robitussin liquid is especially formulated to provide soothing action, control your child’s cough plus relieve other cold symptoms. Should be 18 or older to purchase PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org Distributed by: GSK Consumer Healthcare, Warren, NJ 07059 For most recent product information, visit www.robitussin.com Trademarks owned or licensed by GSK. ©2022 GSK or licensor Made in Canada", "Questions or comments?": "call weekdays from 9 AM to 5 PM EST at 1-800-245-1040", "PRINCIPAL DISPLAY PANEL": "Children's Robitussin FOR AGES 4 & OVER Cough & Cold CF DEXTROMETHORPHAN HBr (Cough Suppressant) GUAIFENESIN (Expectorant) PHENYLEPHRINE HCl (Nasal Decongestant) Relieves: Cough Chest Congestion/Mucus Stuffy Nose Non-Drowsy grape flavor 4 FL OZ (118 mL) PAA172104 Front Carton", "Stop use and ask a doctor if": "you get nervous, dizzy, or sleepless symptoms do not get better within 7 days or are accompanied by fever cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.", "Active ingredients (in each 10 mL)": "Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 100 mg Phenylephrine HCl, USP 5 mg", "Ask a doctor before use if you have": "heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:52.782015 · Updated: 2026-03-14T23:02:39.250584