Label: CAREALL NON ASPIRIN EXTRA STRENGTH- acetaminophen tablet

  • NDC Code(s): 51824-049-01, 51824-049-24
  • Packager: New World Imports, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 2, 2019

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

    In case of accidental overdose, contact a doctor or Poison Control Center immediately.  Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.  ​Do not exceed recommended dosage.

  • INDICATIONS & USAGE

    Temporary relief of minor aches and pains associated with: common cold, headache, toothache, muscular  aches, backache, arthritis, menstrual cramps, and reduction in fever.

  • WARNINGS

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

    -more than 4000 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.

    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.

    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

    -You may report side effects to 1-888-952-0050

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

    Do not exceed recommended dosage.

  • DOSAGE & ADMINISTRATION

    ​Do not use more than directed (see overdose warnings)

    Adults and children 12 years of age and older: Take 2 caplets every 4 to 6 hours as needed.  Do not take more than 8 caplets in 24 hours.  ​Do not use more than 10 days unless directed by a doctor.

    Children under 12 years of age: Do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

  • INACTIVE INGREDIENT

    Corn Starch, Pregelatinized Starch, Stearic Acid.  May contain providone and sodium starch glycolates

  • PRINCIPAL DISPLAY PANEL

    Label Image.jpg

  • INGREDIENTS AND APPEARANCE
    CAREALL NON ASPIRIN  EXTRA STRENGTH
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-049
    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)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Povidone (UNII: FZ989GH94E)  
    Sodium Starch Glycolate Type A Potato (UNII: 5856J3G2A2)  
    Product Characteristics
    Colorwhite (White) Scoreno score
    ShapeOVAL (Oval) Size18mm
    FlavorImprint Code AZ;328
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51824-049-2424 in 1 CASE09/17/2015
    1NDC:51824-049-01100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34309/17/2015
    Labeler - New World Imports, Inc (075372276)