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 6, 2024

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 US

  • 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)

    Robitussin Honey SC F+ST NT 4 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)