Drug Facts

Drug Facts

SPL v9

SPL

SPL Set ID 89360fa8-014d-4da8-bb1c-197e3aa52256

Route

ORAL

Published

Effective Date 2022-06-08

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Acetaminophen (650 mg) Diphenhydramine (25 mg) Phenylephrine (10 mg)

Inactive Ingredients

Anhydrous Citric Acid Edetate Disodium Fd&c Red No. 40 Glycerin Menthol, Unspecified Form Polyethylene Glycol, Unspecified Propyl Gallate Propylene Glycol Water Sodium Benzoate Sodium Citrate, Unspecified Form Sorbitol Sucralose

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

OTC MONOGRAPH DRUG Active Since 2015-07-01

Description

Acetaminophen, USP 650 mg Diphenhydramine HCl, USP 25 mg Phenylephrine HCl, USP 10 mg

Purpose

Pain reliever/Fever reducer Antihistamine/Cough suppressant Nasal decongestant

Medication Information

Purpose

Pain reliever/Fever reducer Antihistamine/Cough suppressant Nasal decongestant

Description

Acetaminophen, USP 650 mg Diphenhydramine HCl, USP 25 mg Phenylephrine HCl, USP 10 mg

Uses

temporarily relieves these symptoms occurring with a cold or flu, hay fever, or other respiratory allergies:
- cough due to minor throat and bronchial irritation
- nasal congestion
- headache
- sore throat
- minor aches and pains
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose and throat
temporarily reduces fever

Section 44425-7

Other information

each 20 mL contains:sodium 12 mg
store at 20-25°C (68-77°F)

Section 50565-1

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

Section 50570-1

Do not use

to sedate a child or to make a child sleepy
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.
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist.
with any other product containing diphenhydramine, even one used on skin

Section 51727-6

Inactive ingredients

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

Section 53414-9

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

Purposes

Pain reliever/Fever reducer

Antihistamine/Cough suppressant

Nasal decongestant

Directions

do not take more than 6 doses in any 24-hour period
do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
measure only with dosing cup provided
keep dosing cup with product
mL = milliliter
this adult product is not intended for use in children under 12 years of age

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

Liver Warning:

This product contains acetaminophen. Severe liver damage may occur if you take

more than 6 doses in any 24-hour period, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Allergy alert:acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore Throat Warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Additional Information

Packaged with Tamper-Evident bottle cap.

Do Not Use if breakable ring is separated or missing.

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

ADULT

Robitussin

MAXIMUM STRENGTH

SEVERE

Multi-Symptom

Cough Cold + Flu

Nighttime

ACETAMINOPHEN (Pain Reliever/Fever Reducer)

DIPHENHYDRAMINE HCI (Antihistamine/Cough Suppressant)

PHENYLEPHRINE HCI (Nasal Decongestant)

Cough, Sore Throat

Body Aches, Fever

Nasal Congestion

Runny Nose

POWERFUL

Multi-symptom relief

CF NIGHTTIME MAX

For Ages 12 & Over

4 FL OZ (118 mL)

62000000077079 Front Carton

When Using This Product

do not use more than directed
marked drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children

Stop Use and Ask A Doctor If

you get nervous, dizzy, or sleepless
pain, cough, or nasal congestion gets worse or lasts more than 7 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

Active Ingredients (in Each 20 Ml)

Acetaminophen, USP 650 mg

Diphenhydramine HCl, USP 25 mg

Phenylephrine HCl, USP 10 mg

Ask A Doctor Before Use If You Have

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin
taking any other oral nasal decongestant or stimulant
taking any other pain reliever/fever reducer
taking sedatives or tranquilizers

Structured Label Content

Uses

temporarily relieves these symptoms occurring with a cold or flu, hay fever, or other respiratory allergies:
- cough due to minor throat and bronchial irritation
- nasal congestion
- headache
- sore throat
- minor aches and pains
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose and throat
temporarily reduces fever

Section 44425-7 (44425-7)

Other information

each 20 mL contains:sodium 12 mg
store at 20-25°C (68-77°F)

Section 50565-1 (50565-1)

Section 50570-1 (50570-1)

Do not use

to sedate a child or to make a child sleepy
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.
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist.
with any other product containing diphenhydramine, even one used on skin

Section 51727-6 (51727-6)

Inactive ingredients

Section 53414-9 (53414-9)

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

Purposes

Pain reliever/Fever reducer

Antihistamine/Cough suppressant

Nasal decongestant

Directions

do not take more than 6 doses in any 24-hour period
do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
measure only with dosing cup provided
keep dosing cup with product
mL = milliliter
this adult product is not intended for use in children under 12 years of age

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

Liver Warning: (Liver warning:)

This product contains acetaminophen. Severe liver damage may occur if you take

more than 6 doses in any 24-hour period, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Allergy alert:acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore Throat Warning (Sore throat warning)

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Additional Information

Packaged with Tamper-Evident bottle cap.

Do Not Use if breakable ring is separated or missing.

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

ADULT

Robitussin

MAXIMUM STRENGTH

SEVERE

Multi-Symptom

Cough Cold + Flu

Nighttime

ACETAMINOPHEN (Pain Reliever/Fever Reducer)

DIPHENHYDRAMINE HCI (Antihistamine/Cough Suppressant)

PHENYLEPHRINE HCI (Nasal Decongestant)

Cough, Sore Throat

Body Aches, Fever

Nasal Congestion

Runny Nose

POWERFUL

Multi-symptom relief

CF NIGHTTIME MAX

For Ages 12 & Over

4 FL OZ (118 mL)

62000000077079 Front Carton

When Using This Product (When using this product)

do not use more than directed
marked drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children

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

you get nervous, dizzy, or sleepless
pain, cough, or nasal congestion gets worse or lasts more than 7 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

Active Ingredients (in Each 20 Ml) (Active ingredients (in each 20 mL))

Acetaminophen, USP 650 mg

Diphenhydramine HCl, USP 25 mg

Phenylephrine HCl, USP 10 mg

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

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

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin
taking any other oral nasal decongestant or stimulant
taking any other pain reliever/fever reducer
taking sedatives or tranquilizers

Advanced Ingredient Data

[{"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "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": "MENTHOL, UNSPECIFIED FORM", "unii": "L7T10EIP3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYL GALLATE", "unii": "8D4SNN7V92", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "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": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "650", "strengthDenominator": "20", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "20", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "20", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms occurring with a cold or flu, hay fever, or other respiratory allergies: cough due to minor throat and bronchial irritation nasal congestion headache sore throat minor aches and pains runny nose sneezing itchy, watery eyes itching of the nose and throat temporarily reduces fever", "44425-7": "Other information each 20 mL contains: sodium 12 mg store at 20-25°C (68-77°F)", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.", "50570-1": "Do not use to sedate a child or to make a child sleepy 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. with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on skin", "51727-6": "Inactive ingredients anhydrous citric acid, artificial flavor, edetate disodium, FD&C red no. 40, glycerin, menthol, polyethylene glycol, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purposes": "Pain reliever/Fever reducer Antihistamine/Cough suppressant Nasal decongestant", "Directions": "do not take more than 6 doses in any 24-hour period do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage. measure only with dosing cup provided keep dosing cup with product mL = milliliter this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 20 mL every 4 hours children under 12 years do not use", "Liver warning:": "This product contains acetaminophen. Severe liver damage may occur if you take more than 6 doses in any 24-hour period, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away.", "Sore throat warning": "If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.", "Additional Information": "Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing. 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": "ADULT Robitussin MAXIMUM STRENGTH SEVERE Multi-Symptom Cough Cold + Flu Nighttime ACETAMINOPHEN (Pain Reliever/Fever Reducer) DIPHENHYDRAMINE HCI (Antihistamine/Cough Suppressant) PHENYLEPHRINE HCI (Nasal Decongestant) Cough, Sore Throat Body Aches, Fever Nasal Congestion Runny Nose POWERFUL Multi-symptom relief CF NIGHTTIME MAX For Ages 12 & Over 4 FL OZ (118 mL) 62000000077079 Front Carton", "When using this product": "do not use more than directed marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children", "Stop use and ask a doctor if": "you get nervous, dizzy, or sleepless pain, cough, or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.", "Active ingredients (in each 20 mL)": "Acetaminophen, USP 650 mg Diphenhydramine HCl, USP 25 mg Phenylephrine HCl, USP 10 mg", "Ask a doctor before use if you have": "liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland glaucoma a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus)", "Ask a doctor or pharmacist before use if you are": "taking the blood thinning drug warfarin taking any other oral nasal decongestant or stimulant taking any other pain reliever/fever reducer taking sedatives or tranquilizers"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:56.866966 · Updated: 2026-03-14T23:02:45.179164