SPL v7
SPL
SPL Set ID 7decc168-e847-4bbe-910b-26081469406f
Route
ORAL
Published
Effective Date 2024-04-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Diphenhydramine (25 mg)
Inactive Ingredients
Anhydrous Citric Acid Carboxymethylcellulose Sodium, Unspecified Glycerin Honey Polyethylene Glycol, Unspecified Propylene Glycol Water Sodium Benzoate Sodium Citrate, Unspecified Form Sodium Gluconate Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-06-15

Description

Drug Facts

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 upper respiratory allergies:
    • cough due to minor throat and bronchial irritation
    • minor aches and pains
    • sore throat pain
    • headache
    • runny nose, sneezing, itchy watery eyes
    • itching of the nose and throat
  • temporarily relieves your cough to help you sleep
  • 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

Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information

  • each 20 mL contains: sodium 22 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.
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 51727-6

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, glycerin, natural & artificial flavors, natural grade A honey, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum

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.

Section 55106-9

Active ingredients (in each 20 mL)

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

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 product containing diphenhydramine, even one used on skin
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

Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing.

Distributed by: Haleon, Warren, NJ 07059

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

Trademarks owned or licensed by Haleon.

©2023 Haleon or licensor.

Pat. Info www.productpats.com

Made in Canada

Principal Display Panel

ADULT

Robitussin

Honey

Nighttime

SEVERE

Cough, Flu +

Sore Throat

ACETAMINOPHEN (Pain Reliever/Fever Reducer)

DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)

MAXIMUM STRENGTH

  • Controls Cough
  • Relieves Runny Nose & Sneezing
  • Relieves Fever & Body Aches

Taste the Real Honey

with Vanilla

CF

NIGHTTIME

MAX

For Ages 12+

8 FL OZ (237 mL)

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
  • 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.
Ask A Doctor Before Use If You Have
  • liver disease
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, emphysema or chronic bronchitis
  • if you have glaucoma or difficulty in urination due to enlargement of prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin
  • taking any other pain reliever/fever reducer

Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporarily relieves these symptoms occurring with a cold or flu, hay fever, or other upper respiratory allergies:
    • cough due to minor throat and bronchial irritation
    • minor aches and pains
    • sore throat pain
    • headache
    • runny nose, sneezing, itchy watery eyes
    • itching of the nose and throat
  • temporarily relieves your cough to help you sleep
  • 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

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information

  • each 20 mL contains: sodium 22 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.
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. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

Section 51727-6 (51727-6)

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, glycerin, natural & artificial flavors, natural grade A honey, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum

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.

Section 55106-9 (55106-9)

Active ingredients (in each 20 mL)

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Purpose

Pain reliever/Fever reducer

Antihistamine/Cough suppressant

Do Not Use (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 product containing diphenhydramine, even one used on skin
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)

Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing.

Distributed by: Haleon, Warren, NJ 07059

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

Trademarks owned or licensed by Haleon.

©2023 Haleon or licensor.

Pat. Info www.productpats.com

Made in Canada

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

ADULT

Robitussin

Honey

Nighttime

SEVERE

Cough, Flu +

Sore Throat

ACETAMINOPHEN (Pain Reliever/Fever Reducer)

DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)

MAXIMUM STRENGTH

  • Controls Cough
  • Relieves Runny Nose & Sneezing
  • Relieves Fever & Body Aches

Taste the Real Honey

with Vanilla

CF

NIGHTTIME

MAX

For Ages 12+

8 FL OZ (237 mL)

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)
  • 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.
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, emphysema or chronic bronchitis
  • if you have glaucoma or difficulty in urination due to enlargement of prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin
  • taking any other pain reliever/fever reducer

Advanced Ingredient Data


Raw Label Data

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