Label: CAREALL ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet

  • NDC Code(s): 51824-060-01, 51824-060-02
  • Packager: New World Imports, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 15, 2023

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

  • Active Ingredient

    Acteminophen 500 mg

  • 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 (1-800-222-1222) right away.  Quick medical attention is critical for adults as well as for children even if you don't notice any signs or symptoms.

  • Uses

    For the temporary of minor aches and pains associated with: common cold, headache, toothache, muscular  aches, backache, arthritis, premenstrual and menstrual cramps

    Temporarily reduces fever.

  • Warnings

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

    -Adults take more than 4,000mg 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.

    Do not use:

    -If you are allergic to Acetaminophen

    -With other products 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

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

    Stop use and ask a doctor if:

    -Symptoms do not improve

    -Pain gets worse or lasts for more than 10 days

    -Fever gets worse or lasts for more than 3 days

    -New symptoms occur

    -Redness or swelling is present

    -A rare sensitivity reaction occurs

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

  • DOSAGE & ADMINISTRATION

    Do not use more than directed (see overdose warning)  

    Adults and children 12 years of age and older: Take 2 tablets every 6 hours as needed.  Do not take more than 6 tablets in 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: consult a doctor

  • INACTIVE INGREDIENT

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

  • PRINCIPAL DISPLAY PANEL

    APAP label
  • INGREDIENTS AND APPEARANCE
    CAREALL ACETAMINOPHEN  EXTRA STRENGTH
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-060
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen500 mg
    Inactive Ingredients
    Ingredient NameStrength
    Starch, Corn (UNII: O8232NY3SJ)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Povidone (UNII: FZ989GH94E)  
    Sodium starch glycolate Type A potato (UNII: 5856J3G2A2)  
    Product Characteristics
    Colorwhite (White) Scoreno score
    ShapeROUND (round) Size12mm
    FlavorImprint Code AZ;011
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51824-060-0224 in 1 CASE04/15/2016
    1NDC:51824-060-01100 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)