Medline Acetaminophen description, usages, side effects, indications, overdosage, supplying and lots more!

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Medline Acetaminophen

Medline Industries, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ACTIVE INGREDIENT (IN EACH CAPLET)

Acetaminophen USP, 500 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. The maximum daily dose of this product is 6 tables (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

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
  • •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)

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 hoursunless 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

  • •store at room temperature
  • Do not use if imprinted safety seal under cap is broken or missing

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 53329-641-98

Compare to the Active Ingredient in Extra Strength Tylenol®

ACETAMINOPHEN

Extra Strength Pain Reliever

PAIN RELIEVER

FEVER REDUCER

500 mg

1000 Tablets – 500 mg each

Medline Acetaminophen

Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:53329-641
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 500 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 (round flat faced beveled edge) 12 mm GPI;A5 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53329-641-30 100 in 1 BOTTLE
2 NDC:53329-641-98 1000 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2013-12-26


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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