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: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 9, 2021

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 20 ml)Purposes

    Acetaminophen, USP 650 mg

    Pain reliever/Fever reducer

    Diphenhydramine HCl, USP 25 mg

    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 9 AM to 5 PM EST at 1-800-762-4675

  • SPL UNCLASSIFIED SECTION

    Distributed by: Pfizer, Madison, NJ 07940 USA

  • PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label

    ADULT
    Robitussin®

    Honey
    MAXIMUM STRENGTH
    Nighttime

    SEVERE
    Cough, Flu +
    Sore Throat

    CF
    NIGHTTIME
    MAX

    ACETAMINOPHEN (Pain Reliever/Fever Reducer)
    DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)

    4 FL OZ (118 ml)

    Principal Display Panel - 118 ml Bottle Label
  • PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton

    ADULT
    NEW!

    Robitussin®

    Honey

    Nighttime

    SEVERE
    Cough, Flu +
    Sore Throat

    ACETAMINOPHEN (Pain Reliever/Fever Reducer)
    DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)

    MAXIMUM STRENGTH

    1.
    Controls Cough
    2.
    Relieves Runny Nose & Sneezing
    3.
    Relieves Fever & Body Aches

    Taste the Real Honey
    with Vanilla

    TRUE
    SOURCE
    CERTIFIED
    HONEY✔™

    CF
    NIGHTTIME
    MAX

    For Ages 12+

    4 FL OZ (118 ml)

    Principal Display Panel - 118 ml Bottle Carton
  • PRINCIPAL DISPLAY PANEL - 237 ml Bottle Label

    ADULT
    Robitussin®

    Honey
    MAXIMUM STRENGTH
    Nighttime

    SEVERE
    Cough, Flu +
    Sore Throat

    CF
    NIGHTTIME
    MAX

    ACETAMINOPHEN (Pain Reliever/Fever Reducer)
    DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)

    8 FL OZ (237 ml)

    Principal Display Panel - 237 ml Bottle Label
  • PRINCIPAL DISPLAY PANEL - 237 ml Bottle Carton

    ADULT
    NEW!

    Robitussin®

    Honey

    Nighttime

    SEVERE
    Cough, Flu +
    Sore Throat

    ACETAMINOPHEN (Pain Reliever/Fever Reducer)
    DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)

    MAXIMUM STRENGTH

    1.
    Controls Cough
    2.
    Relieves Runny Nose & Sneezing
    3.
    Relieves Fever & Body Aches

    Taste the Real Honey
    with Vanilla

    TRUE
    SOURCE
    CERTIFIED
    HONEY✔™

    CF
    NIGHTTIME
    MAX

    For Ages 12+

    8 FL OZ (237 ml)

    Principal Display Panel - 237 ml Bottle Carton
  • 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 FORM (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 FINALpart34106/15/2020
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)