Label: CAREALL ACETAMINOPHEN- acetaminophen tablet

  • NDC Code(s): 51824-061-01, 51824-061-02
  • Packager: New World Imports, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 30, 2023

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  • 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, contact a doctor or Poison Control Center immediately.  Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Uses

    • Temporary relief of minor aches and pains associated with: headache, muscular aches, backache, minor pain from arthritis, the common cold, toothache, premenstrual and menstrual cramps
    • Temporarily reduces fever
  • WARNINGS

    Liver warning: This product contains acetaminophen.  The manxium daily dose of this product is 10 tablets (3,250 mg) in 24 hours fro adults or 5 tablets (1,625 mg) in 24 hours for children.

    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.

    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.
    • is a child with pain of arthritis

    Stop use and ask a doctor if:

    • Adults pain gets worse or lasts for more than 10 days.  
    • Childs pain gets worse or last fr more than 5 days.
    • Fever gets worse or lasts for more than 3 days.  
    • New symptoms occur.  
    • Redness or swelling is present.  

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

    Overdose warning: taking more than the recommended dose (overdose) may cause liver damage.  In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.  Quick medical action is critical for adults as well as for children, even if you do not notice any signs or symptoms.

  • 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, unless directed by a doctor.  do not take 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 more than 5 days unless directed by a doctor.

    Children under 6 years of age: Ask a doctor

  • INACTIVE INGREDIENT

    Corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

  • PRINCIPAL DISPLAY PANEL

    image ACT32524
  • INGREDIENTS AND APPEARANCE
    CAREALL ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-061
    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 ) Scoreno score
    ShapeROUND (Round Circle) Size11mm
    FlavorImprint Code AZ;010
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51824-061-0224 in 1 CASE04/15/2016
    1NDC:51824-061-01100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01304/15/2016
    Labeler - New World Imports, Inc (075372276)