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

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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 500 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 6 tablets (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.

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

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 6 hours while symptoms last
  • swallow whole – do not crush, chew, or dissolve
  • do not take more than 6 tablets in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
children under 12 years
  • ask a doctor

Acetaminophen Other information

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

Inactive ingredients

acesulfame potassium, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

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

PRINCIPAL DISPLAY PANEL - 50 Tablet Bottle Carton

RESTORE u

NDC 57344-092-03

COMPARE TO THE ACTIVE
INGREDIENT IN TYLENOL®
EXTRA STRENGTH EZ TABS

EXTRA
STRENGTH
CONTAINS NO ASPIRIN

EASY TABS

Easy To
Swallow
Sweet Coated

Pain Relief
Pain Reliever, Fever Reducer

Contains Acetaminophen

50 TABLETS - 500 mg each

Acetaminophen

Acetaminophen

Acetaminophen TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:57344-092
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
ACESULFAME POTASSIUM
FD&C RED NO. 40
ALUMINUM OXIDE
FD&C YELLOW NO. 6
HYPROMELLOSES
POLYETHYLENE GLYCOLS
polysorbate 80
POVIDONES
STARCH, CORN
sodium starch glycolate type a corn
STEARIC ACID
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
RED 11 mm A92 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 BOTTLE, PLASTIC
2 50 in 1 BOTTLE, PLASTIC
3 100 in 1 BOTTLE, PLASTIC
4 250 in 1 BOTTLE, PLASTIC
5 NDC:57344-092-04 150 in 1 BOTTLE, PLASTIC

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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