EXTRA STRENGTH ACETAMINOPHEN TABLET [CONTRACT PHARMACY SERVICES-PA]

EXTRA STRENGTH ACETAMINOPHEN TABLET [CONTRACT PHARMACY SERVICES-PA]
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NDC 67046-027-30, 67046-027-60, 67046-027-62
Set ID b74b720d-3692-44f1-ab40-55ff612a95a6
Category HUMAN OTC DRUG LABEL
Packager Contract Pharmacy Services-PA
Generic Name
Product Class
Product Number
Application Number PART343
  • DRUG FACTS

  • ACTIVE INGREDIENT (IN EACH CAPLET)

    Acetaminophen Caplets, 500 mg

  • PURPOSE

    Pain reliever/fever reducer

  • USES

    • temporarily reduces fever
    • temporarily relieves minor aches and pains due to:
      1. headache
      2. muscular aches
      3. the common cold
      4. minor pain of arthritis
      5. backache
      6. toothache
      7. premenstrual and menstrual cramps
  • WARNINGS

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

    • more than 8 tablets in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    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.

    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 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 tablets every 4 to 6 hours while symptoms last
    • do not take more than 8 tablets in 24 hours
    • do not take for more than 10 days unless directed by a doctor
    do not use adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
  • OTHER INFORMATION

    store at 15° to 30°C (59° to 86°F)

  • INACTIVE INGREDIENTS

    povidone, pregelatinized starch, stearic acid

  • QUESTIONS OR COMMENTS?

    Distributed by: Marlex Pharmaceuticals, 50 McCullough Drive, New Castle, DE 19720, U.S.A.

    call toll free 1-866-820-7381

    Repackaged by:

    Contract Pharmacy Services-PA
    125 Titus Ave Suite 200
    Warrington, PA 18976 USA

    Original--08/2010--NJW

  • Package Label

    500 mg Caplets

    500 mg Caplets

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH ACETAMINOPHEN 
    extra strength acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67046-027(NDC:10135-144)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVAL ((capsule-shaped)) Size17mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67046-027-3030 in 1 BLISTER PACK
    2NDC:67046-027-6060 in 1 BLISTER PACK
    3NDC:67046-027-6260 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34308/02/2010
    Labeler - Contract Pharmacy Services-PA (945429777)

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