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Acetaminophen by PD-Rx Pharmaceuticals, Inc.

Medically reviewed on January 12, 2018

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: PD-Rx Pharmaceuticals, Inc.
NDC Code: 55289-880

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.

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 500mg

Purpose

Pain reliever/fever reducer

Uses

Temporarily relieves minor aches and pains due to:

  • the commom cold
  • headache
  • backache
  • minor pain of arthritis
  • toothache
  • muscular aches
  • menstrual cramps

Temporarily reduces fever

Warnings

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 8 tablets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

    Allergy warning:Acetaminophen may cause severe skin reaction. Symptoms may include:
    • skin reddening
    • blisters
    • rash
    • If a skin reaction occurs, stop use and seek medical help right away.

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 the case of overdose, get medical help or contact a Poison Control Center right away.(1-800-222-1222).

Directions
  • do not take more than directed (see overdose warning).
  • Adult and Children 12 years and over: take 2 tablets, every 4 to 6 hours while symptoms last. Do not take more than 6 tablets in 24 hours unless directed by a doctor. Do not take for more than 10 days unless directed by a doctor.
  • Children under 12 years: Ask a doctor.

Inactive ingredients

Povidone, Pregelatinized corn starch, sodium starch glycolate, stearic acid.

Questions?

Adverse drug event call: (866) 562-2756 Mon-Fri 8AM to 4PM

16 HOW SUPPLIED/STORAGE AND HANDLING

Acetaminophen tablets, 500mg, are available for oral administration as white, round, imprinted with PH044 .

Bottles of 24 (NDC 55289-880-24)

Bottles of 30 (NDC 55289-880-30)

Bottles of 100 (NDC 55289-880-01)

Storage Store at 20°C to 25°C (68°F to 77°F) 

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55289-880(NDC:16103-376)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE K30 
STARCH, CORN 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize12mm
FlavorImprint CodePH044
Contains    
Packaging
#Item CodePackage Description
1NDC:55289-880-2424 TABLET in 1 BOTTLE, PLASTIC
2NDC:55289-880-3030 TABLET in 1 BOTTLE, PLASTIC
3NDC:55289-880-01100 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/12/2018
Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
NameAddressID/FEIOperations
PD-Rx Pharmaceuticals, Inc.156893695repack(55289-880)

 
PD-Rx Pharmaceuticals, 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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