Your browser does not support JavaScript! ACETAMINOPHEN TABLET, COATED [AAA PHARMACEUTICAL, INC.]
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RxNorm Names

ACETAMINOPHEN tablet, coated
[AAA Pharmaceutical, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:57344-092
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen500 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorREDScoreno score
ShapeROUNDSize11mm
FlavorImprint Code A92
Contains    
Packaging
#Item CodePackage Description
1NDC:57344-092-021 in 1 CARTON
124 in 1 BOTTLE, PLASTIC
2NDC:57344-092-031 in 1 CARTON
250 in 1 BOTTLE, PLASTIC
3NDC:57344-092-011 in 1 CARTON
3100 in 1 BOTTLE, PLASTIC
4NDC:57344-092-051 in 1 CARTON
4250 in 1 BOTTLE, PLASTIC
5NDC:57344-092-04150 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34312/13/2012
Labeler - AAA Pharmaceutical, Inc. (181192162)
Establishment
NameAddressID/FEIBusiness Operations
AAA Pharmaceutical, Inc.181192162MANUFACTURE(57344-092)
Establishment
NameAddressID/FEIBusiness Operations
AAA Pharmaceutical, Inc.010411533PACK(57344-092)

Revised: 12/2012
Document Id: c139cf5d-3428-4271-ada1-f20b434dcbcb
Set id: a680d30b-9045-4cb5-ac0e-12b95807e460
Version: 1
Effective Time: 20121218
 
AAA Pharmaceutical, Inc.

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