Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID 721bfee2-0d3d-4d8b-beee-1ea83064d1c8

Route

ORAL

Published

Effective Date 2024-01-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Acetaminophen (650 mg) Diphenhydramine (25 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 2024-02-15

Description

Acetaminophen 650 mg Diphenhydramine HCl 25 mg

Purpose

Pain reliever/Fever reducer Antihistamine/Cough suppressant

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

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
- headache
- sore throat
- minor aches and pains
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
temporarily relieves your cough to help you rest
temporarily reduces fever

Purpose

Pain reliever/Fever reducer Antihistamine/Cough suppressant

Dosage and Administration

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

age

dose

adults and children

12 years and over

20 mL every 4 hours

children under 12 years

do not use

Description

Acetaminophen 650 mg Diphenhydramine HCl 25 mg

Section 42229-5

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.

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 50566-9

Stop use and ask a doctor if

pain or cough 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.

Section 50568-5

Ask a doctor or pharmacist before use if you are

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

Section 50569-3

Ask a doctor before use if you have

liver disease
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)

Section 50570-1

Do not use

to sedate a child or to make a child sleepy
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 drug 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 53413-1

Questions or comments?

call weekdays from 8 AM to 6 PM EST at 1-800-245-1040

Section 53414-9

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

Purposes

Pain reliever/Fever reducer

Antihistamine/Cough suppressant

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

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

Do Not Use if breakable ring on bottle cap is separated or missing.

ADULT

Robitussin

MAXIMUM STRENGTH

SEVERE MULTI-SYMPTOM

Cough Cold + Flu CFNIGHTTIME MAX

Distributed by: Haleon, Warren, NJ 07059

For most recent product information, visit www.robitussin.com

Trademarks owned or licensed by Haleon.

Pat. Info www.productpats.com

Principal Display Panel

ADULT NEW FORMULA HALEON

Robitussin

MAXIMUM STRENGTH

SEVERE

MULTI-SYMPTOM

Cough Cold + Flu

Nighttime

ACETAMINOPHEN (Pain Reliever/Fever Reducer)

DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)

Relieves Cough to Help You Rest

✓Cough, Sore Throat

✓Head & Body Aches, Fever

✓Runny Nose, Sneezing

FAST, POWERFUL

multi-symptom relief

CF

NIGHTTIME

MAX

For Ages 12 & Over

4 FL OZ (237 mL)

207723 Front Carton

When Using This Product

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

Active Ingredients (in Each 20 Ml)

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Structured Label Content

Indications and Usage (34067-9)

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
- headache
- sore throat
- minor aches and pains
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
temporarily relieves your cough to help you rest
temporarily reduces fever

Dosage and Administration (34068-7)

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

age

dose

adults and children

12 years and over

20 mL every 4 hours

children under 12 years

do not use

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

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.

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 50566-9 (50566-9)

Stop use and ask a doctor if

pain or cough 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.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

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

Section 50569-3 (50569-3)

Ask a doctor before use if you have

liver disease
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)

Section 50570-1 (50570-1)

Do not use

to sedate a child or to make a child sleepy
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 drug containing diphenhydramine, even one used on skin

Section 51727-6 (51727-6)

Inactive ingredients

Section 53413-1 (53413-1)

Questions or comments?

call weekdays from 8 AM to 6 PM EST at 1-800-245-1040

Section 53414-9 (53414-9)

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

Purposes

Pain reliever/Fever reducer

Antihistamine/Cough suppressant

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

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 (Additional information)

Do Not Use if breakable ring on bottle cap is separated or missing.

ADULT

Robitussin

MAXIMUM STRENGTH

SEVERE MULTI-SYMPTOM

Cough Cold + Flu CFNIGHTTIME MAX

Distributed by: Haleon, Warren, NJ 07059

For most recent product information, visit www.robitussin.com

Trademarks owned or licensed by Haleon.

Pat. Info www.productpats.com

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

ADULT NEW FORMULA HALEON

Robitussin

MAXIMUM STRENGTH

SEVERE

MULTI-SYMPTOM

Cough Cold + Flu

Nighttime

ACETAMINOPHEN (Pain Reliever/Fever Reducer)

DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)

Relieves Cough to Help You Rest

✓Cough, Sore Throat

✓Head & Body Aches, Fever

✓Runny Nose, Sneezing

FAST, POWERFUL

multi-symptom relief

CF

NIGHTTIME

MAX

For Ages 12 & Over

4 FL OZ (237 mL)

207723 Front Carton

When Using This Product (When using this product)

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

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

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "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 headache sore throat minor aches and pains runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily relieves your cough to help you rest temporarily reduces fever", "34068-7": "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", "34071-1": "Warnings", "42229-5": "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.", "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.", "50566-9": "Stop use and ask a doctor if pain or cough 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.", "50568-5": "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking any other pain reliever/fever reducer taking sedatives or tranquilizers", "50569-3": "Ask a doctor before use if you have liver disease 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)", "50570-1": "Do not use to sedate a child or to make a child sleepy 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 drug 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", "53413-1": "Questions or comments? call weekdays from 8 AM to 6 PM EST at 1-800-245-1040", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purposes": "Pain reliever/Fever reducer Antihistamine/Cough suppressant", "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", "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": "Do Not Use if breakable ring on bottle cap is separated or missing. ADULT Robitussin MAXIMUM STRENGTH SEVERE MULTI-SYMPTOM Cough Cold + Flu CF NIGHTTIME MAX Distributed by: Haleon, Warren, NJ 07059 For most recent product information, visit www.robitussin.com Trademarks owned or licensed by Haleon. Pat. Info www.productpats.com ©2023 Haleon or licensor. Made in Canada", "PRINCIPAL DISPLAY PANEL": "ADULT NEW FORMULA HALEON Robitussin MAXIMUM STRENGTH SEVERE MULTI-SYMPTOM Cough Cold + Flu Nighttime ACETAMINOPHEN (Pain Reliever/Fever Reducer) DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant) Relieves Cough to Help You Rest ✓Cough, Sore Throat ✓Head & Body Aches, Fever ✓Runny Nose, Sneezing FAST, POWERFUL multi-symptom relief CF NIGHTTIME MAX For Ages 12 & Over 4 FL OZ (237 mL) 207723 Front Carton", "When using this product": "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", "Active ingredients (in each 20 mL)": "Acetaminophen 650 mg Diphenhydramine HCl 25 mg"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:47.596811 · Updated: 2026-03-14T23:02:30.868416