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CVS Pharmacy

CVS Pharmacy, Inc. Pain Relief Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

pain relief Uses

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

Warnings

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

  • •adult takes more than 12 tablets in 24 hours, which is the maximum daily amount for this product
  • •child takes more than 5 doses in 24 hours
  • •taken with other drugs containing acetaminophen
  • •adult has 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.

Ask a doctor before use if the user

  • •has liver disease
  • •is a child with pain of arthritis

Ask a doctor or pharmacist before use if the user is

taking the blood thinning drug warfarin

Stop use and ask a doctor if

  • •pain gets worse or lasts for more than 10 days (for adults) or 5 days (for children)
  • •fever gets worse or lasts for 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 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

  • •do not take more than directed (see Liver warning)
take 2 tablets every 4 to 6 hours while symptoms last
  • do not take more than 12 tablets in 24 hourstake 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hoursdo not use this adult Regular Strength product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

    adults and children 12 years and over

    children

    6-11 years

    children under

    6 years

    Inactive ingredients

    croscarmellose sodium*, povidone, pregelatinized starch, stearic acid *may contain this ingredient

    Questions or comments?

    1-800-719-9260

    Principal Display Panel

    Compare to the active ingredient in Tylenol®

    see new warnings information

    Regular Strength

    PAIN RELIEF

    TABLETS

    ACETAMINOPHEN

    CONTAINS NO ASPIRIN

    Pain reliever/ fever reducer

    325 mg each

    pain relief

    Acetaminophen TABLET

    Product Information

    Product Type Human otc drug label Item Code (Source) NDC:59779-766
    Route of Administration ORAL DEA Schedule

    Active Ingredient/Active Moiety

    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN ACETAMINOPHEN 325 mg

    Inactive Ingredients

    Ingredient Name Strength
    CROSCARMELLOSE SODIUM
    povidone
    STEARIC ACID

    Product Characteristics

    Color Size Imprint Code Shape
    WHITE 10 mm 325MG;L403 ROUND

    Packaging

    # Item Code Package Description Marketing Start Date Marketing End Date
    1 100 in 1 BOTTLE
    2 NDC:59779-766-78 1 in 1 CARTON

    Marketing Information

    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    part part343 1991-06-15


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    Be sure to consult your doctor before taking any medication!
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