Label: ROBITUSSIN HONEY SEVERE COUGH, FLU PLUS SORE THROAT NIGHTTIME- acetaminophen and diphenhydramine hydrochloride solution

  • NDC Code(s): 0031-8770-12, 0031-8770-18
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 26, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 20 mL)

    Acetaminophen 650 mg

    Diphenhydramine HCl 25 mg

  • Purpose

    Pain reliever/Fever reducer

    Antihistamine/Cough suppressant

  • INDICATIONS & 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
  • 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 product containing diphenhydramine, even one used on skin

    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

    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.

    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 22 mg
    •
    store at 20-25°C (68-77°F). Do not refrigerate.
  • INACTIVE INGREDIENT

    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

  • QUESTIONS

    Questions or comments?

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

  • 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)

    Robitussin Honey SC F+ST NT 8 oz
  • INGREDIENTS AND APPEARANCE
    ROBITUSSIN HONEY SEVERE COUGH, FLU PLUS SORE THROAT NIGHTTIME 
    acetaminophen and diphenhydramine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8770
    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)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HONEY (UNII: Y9H1V576FH)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorORANGEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0031-8770-121 in 1 CARTON06/15/2020
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0031-8770-181 in 1 CARTON06/15/2020
    2237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/15/2020
    Labeler - Haleon US Holdings LLC (079944263)
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