Robitussin Maximum Strength Severe Multi-symptom Cough Cold Flu Nighttime Liquid
FDA Label NDC 0031-0101

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Robitussin Maximum Strength Severe Multi-symptom Cough Cold Flu Nighttime (NDC 0031-0101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (in each 20 ml), purposes, indications & usage, warnings, liver warning:, other, sore throat warning:, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients (In Each 20 Ml)

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Purposes

Pain reliever/Fever reducer

Antihistamine/Cough suppressant

Indications & 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

Warnings

Warnings

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

Other

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.

Otc - 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 drug containing diphenhydramine, even one used on skin

Otc - Ask Doctor

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)

Otc - Ask Doctor/Pharmacist

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

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

Otc - Stop Use

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.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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.

Dosage & 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
  • agedose

    adults and children

    12 years and over

    20 mL every 4 hours

    children under 12 years

    do not use

Storage And Handling

Other information

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

Inactive Ingredient

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

Otc - Questions

Questions or comments?

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

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

©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

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