DrugCite

ACETAMINOPHEN - acetaminophen tablet, coated 
AAA Pharmaceutical, Inc.

Acetaminophen Caplets

Drug Facts

Active ingredient (in each caplet)

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 caplets (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 caplets every 6 hours while symptoms last
  • do not take more than 6 caplets 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

hypromellose, mineral oil, 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 - 100 Caplet Bottle Carton

RESTORE u

NDC 57344-004-04

†COMPARE TO THE ACTIVE
INGREDIENT IN TYLENOL®
EXTRA STRENGTH

EXTRA
STRENGTH
CONTAINS NO ASPIRIN

Pain Relief

Pain Reliever, Fever Reducer

Contains Acetaminophen

100 CAPLETS - 500 mg each

Principal Display Panel - 100 Caplet Bottle Carton

ACETAMINOPHEN 
acetaminophen  tablet, coated
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 57344-004
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
HYPROMELLOSES  
MINERAL OIL  
POLYETHYLENE GLYCOLS  
POLYSORBATE 80  
POVIDONES  
STARCH, CORN  
SODIUM STARCH GLYCOLATE TYPE A CORN  
STEARIC ACID  
TITANIUM DIOXIDE  
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 17mm
Flavor Imprint Code M2A4;57344
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 57344-004-01 1  In 1 CARTON contains a BOTTLE, PLASTIC
1 24  In 1 BOTTLE, PLASTIC This package is contained within the CARTON (57344-004-01)
2 57344-004-02 1  In 1 CARTON contains a BOTTLE, PLASTIC
2 50  In 1 BOTTLE, PLASTIC This package is contained within the CARTON (57344-004-02)
3 57344-004-03 100  In 1 BOTTLE, PLASTIC None
4 57344-004-04 1  In 1 CARTON contains a BOTTLE, PLASTIC
4 100  In 1 BOTTLE, PLASTIC This package is contained within the CARTON (57344-004-04)
5 57344-004-05 1  In 1 CARTON contains a BOTTLE, PLASTIC
5 250  In 1 BOTTLE, PLASTIC This package is contained within the CARTON (57344-004-05)
6 57344-004-06 500  In 1 BOTTLE, PLASTIC None
7 57344-004-07 1000  In 1 BOTTLE, PLASTIC None
8 57344-004-08 150  In 1 BOTTLE, PLASTIC None
9 57344-004-09 2  In 1 CARTON contains a BOTTLE, PLASTIC
9 100  In 1 BOTTLE, PLASTIC This package is contained within the CARTON (57344-004-09)
10 57344-004-15 1000  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.