Label: ROBITUSSIN MAXIMUM STRENGTH SEVERE MULTI-SYMPTOM COUGH COLD FLU NIGHTTIME- acetaminophen, diphenhydramine hcl liquid

  • NDC Code(s): 0031-0101-04
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 23, 2024

If you are a consumer or patient please visit this version.

  • 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

    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.

    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

    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)

    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

    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.

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

    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

  • 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

    Robitussin Severe Multi-Symptom CC+F NT 4 fl oz (118 mL)
  • INGREDIENTS AND APPEARANCE
    ROBITUSSIN MAXIMUM STRENGTH SEVERE MULTI-SYMPTOM COUGH COLD FLU NIGHTTIME 
    acetaminophen, diphenhydramine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-0101
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRY, RASPBERRY, Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0031-0101-041 in 1 CARTON02/15/2024
    1118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01202/15/2024
    Labeler - Haleon US Holdings LLC (079944263)