PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [CVS PHARMACY]

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PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [CVS PHARMACY]
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NDC 59779-101-03, 59779-101-11, 59779-101-12
Set ID b09d70df-c6bd-48f7-bda6-473e1560a779
Category HUMAN OTC DRUG LABEL
Packager CVS Pharmacy
Generic Name
Product Class
Product Number
Application Number PART343
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  • Active ingredient (in each tablet)

    Acetaminophen 500 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    • temporarily relieves minor aches and pains due to:
      • headache
      • backache
      • toothache
      • premenstrual and menstrual cramps
      • the common cold
      • minor pain of arthritis
      • muscular aches
    • temporarily reduces fever 
  • Warnings

    Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tablets (3,000 mg) in 24 hours. 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 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

    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts 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.

    Keep out of reach of children.

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

  • Directions

    • do not take more than directed
    • adults and children 12 years and over
      • take 2 tablets every 6 hours while symptoms last
      • 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: ask a doctor
  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    corn starch, povidone, sodium starch glycolate, stearic acid

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    ♥︎CVS Health™

    Compare to the active ingredient in Extra Strength Tylenol®*

    Tablets
    NDC 59779-101-12

    EXTRA STRENGTH
    Pain Relief
    ACETAMINOPHEN,     500 mg
    Pain reliever, Fever reducer
    Aspirin free

    100 TABLETS 

    Actual Size

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol®.

    50844  ORG061514812

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2015 CVS/pharmacy
    CVS.com®   1-800-SHOP CVS

    V-11112

    CVS® Quality
    Money Back Guarantee

    CVS Health 44-148

    CVS Health 44-148

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVER  EXTRA STRENGTH
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-101
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeROUNDSize12mm
    FlavorImprint Code 44;148
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-101-111 in 1 CARTON01/21/199310/20/2019
    160 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:59779-101-121 in 1 CARTON01/21/1993
    2100 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:59779-101-0310 in 1 VIAL, PLASTIC; Type 0: Not a Combination Product01/21/199307/08/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34301/21/1993
    Labeler - CVS Pharmacy (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(59779-101)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(59779-101)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(59779-101)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837MANUFACTURE(59779-101)
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