Medline Acetaminophen

Medline Industries, Inc.

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• ACTIVE INGREDIENT (IN EACH TABLET)
• PURPOSE
• USES
• WARNINGS
  • Do not use
  • Ask a doctor before use if you have
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding
  • Keep out of reach of children.
• DIRECTIONS
• OTHER INFORMATION
• INACTIVE INGREDIENTS
• QUESTIONS?
• PRINCIPAL DISPLAY PANEL
• Side Panel

FULL PRESCRIBING INFORMATION

ACTIVE INGREDIENT (IN EACH TABLET)

Acetaminophen USP, 325 mg

PURPOSE

Pain reliever/fever reducer

USES

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

WARNINGS

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

• •adults take more than 12 tablets in 24 hours, which is the maximum daily amount
• •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.
• •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

If you are taking blood thinning drug warafin

Stop use and ask a doctor if

• •pain gets worse or lasts more than 10 days in adults and children
• •Pain gets worse or lasts more than 5 days in children under 12 years
• •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: 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 overdose 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 hours

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•

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Age	Dose
Adults and children 12 years and over
Children 6-11 years
Children under 6 years	Do not use Regular Strength products in children under 6 years of age; this will provide more than recommended dose (overdose) of acetaminophen and may cause liver damage.

OTHER INFORMATION

• •store at room temperature

INACTIVE INGREDIENTS

Povidone, Pregelatinzed Starch, Sodium Starch Glycolate, Searic Acid.

QUESTIONS?

If you have any questions or comments, or to report an adverse event, please contact 1-800-MEDLINE (633-5463)

PRINCIPAL DISPLAY PANEL

MEDLINE

NDC 53329-642-30

^† Compare to the Active Ingredient in Extra Strength Tylenol®

ACETAMINOPHEN

Regular Strength Pain Reliever

PAIN RELIEVER

FEVER REDUCER

325 mg

100 tablets 325 mg each

Side Panel

Medline Acetaminophen Acetaminophen TABLET Product Information Product Type Human otc drug label Item Code (Source) NDC:53329-642 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 POVIDONES propylene glycol STEARIC ACID sodium starch glycolate type a corn STARCH, CORN Product Characteristics Color Size Imprint Code Shape WHITE 12 mm GPI;A325; ROUND Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53329-642-30 100 in 1 BOTTLE 2 NDC:53329-642-98 1000 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date part part343 2013-12-26