Label: ROBITUSSIN DIRECT SORE THROAT PAIN- acetaminophen tablet, coated

  • NDC Code(s): 0031-9301-01
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 8, 2024

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

  • Active ingredient (in each caplet)

    Acetaminophen 500 mg

  • Purposes

    Pain reliever/Fever reducer

  • Uses

    • temporarily relieves minor aches and pains due to:
    • sore throat
    • headache
    • backache
    • toothache
    • premenstrual and menstrual cramps
    • the common cold
    • minor pain of arthritis
    • muscular aches
    • temporarily reduces fever
  • Warnings

    Liver warning:

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

    • more than 4,000 mg of acetaminophen in 24 hours
    • 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

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • if you are allergic to acetaminophen or any of the inactive ingredients in this product

    Ask a doctor before use if you have liver disease

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

    Stop use and ask a doctor if

    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • 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.

  • Directions

    • do not take more than directed
    • adults and children 12 years of age and over: take 1 caplet every 4 hours, or 2 caplets every 6 hours, while symptoms last
    • do not take more than 6 caplets in any 24 hours, unless directed by a doctor
    • do not take for more than 10 days unless directed by a doctor
    • children under 12 years of age: ask a doctor
  • Other information

    • store at 25°C (77°F)
  • Inactive ingredients

    castor oil, hypromellose, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

  • Questions?call weekdays from 9 AM to 5 PM EST at 1-800-245-1040

  • Additional Information

    Do not use if safety seal under cap printed with “Sealed for Your Protection” is broken or missing.

    Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

    visit www.robitussin.com

    Trademarks owned or licensed by GSK ©2022 GSK or licensor

    Made in China

    Lift Here for More Drug Facts

  • PRINCIPAL DISPLAY PANEL

    NEW

    Robitussin

    Sore Throat Pain

    Acetaminophen
    (Pain Reliever, Fever Reducer)

    direct

    18 Caplets

    Actual size

    L-0630-175-44-UPC_ORG - Front Label

    Robitussin Direct Sore Throat Pain 18 caplets
  • INGREDIENTS AND APPEARANCE
    ROBITUSSIN DIRECT SORE THROAT PAIN 
    acetaminophen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-9301
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    CASTOR OIL (UNII: D5340Y2I9G)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code 44;175
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0031-9301-0118 in 1 BOTTLE; Type 0: Not a Combination Product07/15/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/15/2022
    Labeler - Haleon US Holdings LLC (079944263)