Label: CAREALL ACETAMINOPHEN- acetaminophen tablet

  • NDC Code(s): 51824-085-01
  • Packager: New World Imports, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 30, 2023

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

  • Active Ingredient

    Acetaminophen 325mg

  • Purpose

    Pain reliever / Fever reducer

  • Keep out of Reach of Children

    Keep out of reach of children.

    Overdose warning: In case of  overdose, get medical help or contact a Poison Control Center immediately (1-800-222-1222).  Quick medical attention is critical for adults as well as for chidren even if you do not notice any signs or symptoms.

  • Uses

    Temporary relieves minor aches and pains due to:

    the common cold, headache, toothache, muscular aches, backache, minor pain of arthritis, premenstrual and menstrual cramps, and reduction of fever

  • WARNINGS

    Liver warning: This product contains acetaminophen.  Severe liver damage may occur if:

    Adult takes more than 4,000mg of acetaminphen in 24 hours

    Child takes more than 5 doses in 24 hours

    Taken with other drugs containing acetaminophen

    Adult has 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 or rash.  If a skin reaction occurs, stop use and seek medical help right away.

    Do not use:

    With any other drug containing acetaminophen (prescription or nonprescription). 

    If you are allergic to acetaminophen or any of the inactive ingredients in this product.

    Ask a doctor before use if user has: liver disease

    Ask a doctor or pharmacist before use if:the user is taking the blood thinnig drug warfarin.

    Stop use and ask a doctor if:

    Pain gets worse or lasts for more than 10 days. 

    Pain gets worse or lasts more than 5 days in children under 12 years. 

    Fever gets worse or lasts for more than 3 days. 

    New symptoms occur. 

    Redness or swelling is present. 

    These could be signs of a serious condition.

    If pregnant or breast-feeding,ask a health professional before use. 


  • DOSAGE & ADMINISTRATION

    Adults and children 12 years of age and older: 

    Take 2 tablets every 4 to 6 hours while symptoms last

    Do not take more than 10 tablets in 24 hours.

    Do not use for more than 10 days unless directed by a doctor

    Children 6-11 years of age:

    Take 1 tablet every 4 to 6 hours while symptoms last. 

    Do not take more than 5 tablets in 24 hours.

    Do not use for more than 5 days unless directed by a doctor

    Children under 6 years of age: Ask a doctor

  • INACTIVE INGREDIENT

    povidone, pregelatinized starch, sodium starch glycolate, stearic acid

  • PRINCIPAL DISPLAY PANEL

    ACT32524
  • INGREDIENTS AND APPEARANCE
    CAREALL ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-085
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen325 mg
    Inactive Ingredients
    Ingredient NameStrength
    Starch, Corn (UNII: O8232NY3SJ)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Povidone (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    Product Characteristics
    Colorwhite (white ) Score2 pieces
    ShapeROUND (Round Circle) Size10mm
    FlavorImprint Code M2A3;57344
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51824-085-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/18/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01303/18/2021
    Labeler - New World Imports, Inc (075372276)