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Acetaminophen by AAA Pharmaceutical, Inc.

Dosage form: tablet
Ingredients: Acetaminophen 325mg
Labeler: AAA Pharmaceutical, Inc.
NDC Code: 57344-001

Disclaimer: 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.

Acetaminophen Tablets

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 325 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 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
  • do not take more than directed (see overdose warning)
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

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 tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57344-001
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen325 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONES 
STARCH, CORN 
SODIUM STARCH GLYCOLATE TYPE A CORN 
STEARIC ACID 
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize10mm
FlavorImprint CodeM2A3;57344
Contains    
Packaging
#Item CodePackage Description
1NDC:57344-001-01100 TABLET in 1 BOTTLE, PLASTIC
2NDC:57344-001-021 BOTTLE, PLASTIC in 1 CARTON
2100 TABLET in 1 BOTTLE, PLASTIC
3NDC:57344-001-031000 TABLET in 1 BOTTLE, PLASTIC
4NDC:57344-001-04100 TABLET in 1 BOTTLE, PLASTIC
5NDC:57344-001-051 BOTTLE, PLASTIC in 1 CARTON
550 TABLET in 1 BOTTLE, PLASTIC
6NDC:57344-001-06500 TABLET in 1 BOTTLE, PLASTIC
7NDC:57344-001-071 BOTTLE, PLASTIC in 1 CARTON
724 TABLET in 1 BOTTLE, PLASTIC
8NDC:57344-001-081000 TABLET in 1 BOTTLE, PLASTIC
9NDC:57344-001-9960942 TABLET in 1 CONTAINER
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/FEIOperations
AAA Pharmaceutical, Inc.181192162MANUFACTURE(57344-001)
Establishment
NameAddressID/FEIOperations
AAA Pharmaceutical, Inc.010411533PACK(57344-001)

Revised: 12/2012
 
AAA Pharmaceutical, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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