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Pill Identifier Information of APAP 500 MG Oral Tablet

Drug Information

APAP 500 MG Oral Tablet

Imprint: M2A4;57344
Shape: C48345
Color: C48325
Ingredients: Acetaminophen
Size: 17.00
Score: 1
Rxtty: SY
Author: AAA Pharmaceutical, Inc.
Inactive Ingredients: HYPROMELLOSES / MINERAL OIL / POLYETHYLENE GLYCOLS / POLYSORBATE 80 / POVIDONES / STARCH, CORN / SODIUM STARCH GLYCOLATE TYPE A CORN / STEARIC ACID / TITANIUM DIOXIDE>

Complete Information

  • 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.

    • 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 haveliver disease.

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

    Stop use and ask a doctor if

    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.

    Overdose warning

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

  • Directions

    adults and children 12 years and over
    • take 2 caplets every 6 hours while symptoms last
    • do not take more than 6 caplets in 24 hours, unless directed by a doctor
    • do not use for more than 10 days unless directed by a doctor
    children under 12 years
    • ask a doctor
  • Other information

  • Inactive ingredients

    hypromellose, mineral oil, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

  • Questions or comments?

    1-844-705-4384

  • PRINCIPAL DISPLAY PANEL

    RESTORE U

    NDC 57344-004-04

    †COMPARE TO THE ACTIVE INGREDIENT IN TYLENOL® EXTRA STRENGTH CAPLETS

    For Adults

    EXTRA STRENGTH

    Pain Relief

    Acetaminophen

    Pain Reliever, Fever Reducer

    Actual Size

    100 CAPLETS - 500 MG EACH

    image description

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57344-004
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code M2A4;57344
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57344-004-041 in 1 CARTON04/13/2012
    1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:57344-004-06500 in 1 BOTTLE; Type 0: Not a Combination Product03/15/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01304/13/2012
    Labeler - AAA Pharmaceutical, Inc. (181192162)