DrugCite

ACETAMINOPHEN - acetaminophen tablet, coated 
AAA Pharmaceutical, Inc.

Acetaminophen Tablets

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

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

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

PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Carton

ACETAMINOPHEN 
acetaminophen  tablet, coated
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 57344-092
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (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 RED Score no score
Shape ROUND Size 11mm
Flavor Imprint Code A92
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 57344-092-02 1  In 1 CARTON contains a BOTTLE, PLASTIC
1 24  In 1 BOTTLE, PLASTIC This package is contained within the CARTON (57344-092-02)
2 57344-092-03 1  In 1 CARTON contains a BOTTLE, PLASTIC
2 50  In 1 BOTTLE, PLASTIC This package is contained within the CARTON (57344-092-03)
3 57344-092-01 1  In 1 CARTON contains a BOTTLE, PLASTIC
3 100  In 1 BOTTLE, PLASTIC This package is contained within the CARTON (57344-092-01)
4 57344-092-05 1  In 1 CARTON contains a BOTTLE, PLASTIC
4 250  In 1 BOTTLE, PLASTIC This package is contained within the CARTON (57344-092-05)
5 57344-092-04 150  In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 12/13/2012

Labeler - AAA Pharmaceutical, Inc. (181192162)
Establishment
Name Address ID/FEI Operations
AAA Pharmaceutical, Inc. 181192162 MANUFACTURE
Establishment
Name Address ID/FEI Operations
AAA Pharmaceutical, Inc. 010411533 PACK
Revised: 12/2012AAA Pharmaceutical, Inc.