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Acetaminophen

AAA Pharmaceutical, Inc.

Acetaminophen Tablets


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Acetaminophen Uses

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

Warnings

Liver warning

This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours, which is the maximum daily amount
  • 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 the user is allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if the user has liver disease.

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 more than 10 days in adults
  • 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

adults and children 12 years and over
  • take 2 tablets every 4 to 6 hours while symptoms last
  • do not take more than 10 tablets in 24 hours
  • do not use for more than 10 days unless directed by a doctor
children 6-11 years
  • take 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours
  • do not use for more than 5 days unless directed by a doctor
children under 6 years
  • ask a doctor

Acetaminophen Other information

  • store between 20-25°C (68-77°F)
  • retain carton for complete product information

Inactive ingredients

povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Distributed by:
AAA Pharmaceutical, Inc.
681 Main Street
Lumberton, NJ 08048

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton

RESTORE u

NDC 57344-001-02

COMPARE TO THE ACTIVE
INGREDIENT IN TYLENOL®
REGULAR STRENGTH

REGULAR
STRENGTH
CONTAINS NO ASPIRIN

Pain Relief
Pain Reliever, Fever Reducer

Contains Acetaminophen

100 TABLETS - 325 mg each

Acetaminophen

Acetaminophen

Acetaminophen TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:57344-001
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
STARCH, CORN
sodium starch glycolate type a corn
STEARIC ACID

Product Characteristics

Color Size Imprint Code Shape
WHITE 10 mm M2A3;57344 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57344-001-01 100 in 1 BOTTLE, PLASTIC
2 100 in 1 BOTTLE, PLASTIC
3 NDC:57344-001-03 1000 in 1 BOTTLE, PLASTIC
4 NDC:57344-001-04 100 in 1 BOTTLE, PLASTIC
5 50 in 1 BOTTLE, PLASTIC
6 NDC:57344-001-06 500 in 1 BOTTLE, PLASTIC
7 24 in 1 BOTTLE, PLASTIC
8 NDC:57344-001-08 1000 in 1 BOTTLE, PLASTIC
9 NDC:57344-001-99 60942 in 1 CONTAINER

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2012-12-13


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