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← See all Acetaminophen Regular strength brands

Acetaminophen Regular strength

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg
Labeler: PD-Rx Pharmaceuticals, Inc.
NDC Code: 55289-563

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.


Active ingredient (per tablet)

Acetaminophen 325mg


Pain reliever/Fever reducer

  • Temporarily relieves minor aches and pains due to
    • the common cold
    • headache
    • backache
    • minor pain of arthritis
    • toothache
    • muscular aches
    • menstrual cramps
  • Temporarily reduces fever


Liver warning:This product contains acetaminophen. Severe liver damage may occur if

  • Adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
  • Child takes more than 5 doses in 24 hours
  • 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 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 in adults and children
  • 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 sign of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of the reach of children.

Overdose warning:

Taking more than the recommended dose (overdose) may cause liver damage. In the case of accidental overdose, get medical help or contact a Poison Control Center right away.

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

Adults and children 12 years and over                     
Take 2 tablets every 4 to 6 while symptoms last.
Do not take more than 12 tablets in 24 hours.
Children 6 to under 12 years
Take 1 tablet every 4 to 6 while symptoms last.
Do not take more than 5 tablets in 24 hours.
Children under 6 years
Do not use adult regular strength products in childern under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Other information
  • Tamper Evident: do not use if imprinted safety seal under cap is broken or missing
  • store between 20-25°C (68-77°F)
  • use by expiration date on package

Inactive ingredients:

Povidone, pregelatinized starch, sodium starch glycolate, stearic acid.


Adverse drug event call: (866) 562-2756


Bottles of 4, 6, 12, 20, 24, 30, 50 and 100 tablets.

acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55289-563(NDC:16103-353)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Inactive Ingredients
Ingredient NameStrength
Product Characteristics
ColorwhiteScoreno score
FlavorImprint CodePH020
#Item CodePackage Description
1NDC:55289-563-044 TABLET in 1 BOTTLE, PLASTIC
2NDC:55289-563-066 TABLET in 1 BOTTLE, PLASTIC
3NDC:55289-563-1212 TABLET in 1 BOTTLE, PLASTIC
4NDC:55289-563-2020 TABLET in 1 BOTTLE, PLASTIC
5NDC:55289-563-2424 TABLET in 1 BOTTLE, PLASTIC
6NDC:55289-563-3030 TABLET in 1 BOTTLE, PLASTIC
7NDC:55289-563-5050 TABLET in 1 BOTTLE, PLASTIC
8NDC:55289-563-01100 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/09/2007
Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
PD-Rx Pharmaceuticals, Inc.156893695repack(55289-563)

PD-Rx Pharmaceuticals, Inc.

← See all Acetaminophen Regular strength brands

Medically reviewed on Aug 8, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.