Label: ROBITUSSIN MAXIMUM STRENGTH SEVERE MULTI-SYMPTOM 7 IN 1 RELIEF NIGHTTIME- acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate capsule, liquid filled

  • NDC Code(s): 0031-8744-10
  • 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.

  • Active ingredients (in each liquid-filled capsule)

    Acetaminophen, USP 325 mg

    Dextromethorphan HBr, USP 15 mg

    Doxylamine Succinate, USP 6.25 mg

  • Purposes

    Pain reliever/Fever reducer

    Cough suppressant

    Antihistamine

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves these symptoms occurring with a cold or flu, hay fever, or other upper respiratory allergies:
      • headache
      • sore throat
      • cough
      • minor aches and pains
      • runny nose
      • sneezing
      • itchy, watery eyes
      • itching of the nose or throat
    • temporarily reduces fever
  • WARNINGS

    Warnings

    Liver warning

    This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 8 capsules 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
    • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    Ask a doctor before use if you have

    • liver disease
    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • cough that occurs with too much phlegm (mucus)
    • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

    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
    • cough comes back or occurs with rash or headache that lasts.
      These could be signs of a serious condition.
    • new symptoms occur

    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 8 capsules in any 24-hour period
    • do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
    • this adult product is not intended for use in children under 12 years of age
    agedose

    adults and children 12 years and over

    2 capsules every 6 hours

    children under 12 years

    do not use

  • STORAGE AND HANDLING

    Other information

    • store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).
  • INACTIVE INGREDIENT

    Inactive ingredients

    D&C yellow no. 10, FD&C blue no. 1, gelatin, glycerin, mineral oil, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution

  • 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

    ADULT

    Robitussin ®

    • MAXIMUM
      STRENGTH
    • SEVERE
      Multi-Symptom
      7 in 1 Relief

    ACETAMINOPHEN (Pain Reliever/Fever Reducer)
    DEXTROMETHORPHAN HBr (Cough Suppressant)
    DOXYLAMINE SUCCINATE (Antihistamine)

    CF
    NIGHTTIME
    MAX

    1. Cough, Sore Throat
    2. Body Aches, Fever
    3. Runny Nose, Sneezing
    4. Itchy Throat

    For Ages 12 & Over

    10
    LIQUID-FILLED
    CAPSULES

    Robitussin MS S Multi Sym 10 Caps Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    ROBITUSSIN MAXIMUM STRENGTH SEVERE MULTI-SYMPTOM 7 IN 1 RELIEF NIGHTTIME 
    acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8744
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize16mm
    FlavorImprint Code R
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0031-8744-105 in 1 CARTON07/01/2018
    12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/01/2015
    Labeler - Haleon US Holdings LLC (079944263)