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Acetaminophen by Oxford Pharmaceuticals, LLC

Dosage form: tablet
Ingredients: Acetaminophen 500mg
Labeler: Oxford Pharmaceuticals, LLC
NDC Code: 69584-012

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)Purpose
Acetaminophen USP, 500 mgPain reliever/fever reducer

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

Warnings

Liver warning: This product contains acetaminophen. 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

Allergy alert: acetaminophen may cause severe skin reactions. 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 have ever had an allergic reaction to this product or   any of its ingredients

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: Taking more than the recommended dose (overdose) may cause liver damage. 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 & children 12 years and over:
    • take 1 tablet every 3-4 hours or 2 tablets every 6 hours while symptoms last
    • do not take more than 6 tablets in 24 hours

children under 12 years: ask a doctor

Other information
  • store at 20-25°C (68-77°F)

Inactive ingredients croscarmellose sodium, hypromellose, polyethylene glycol, povidone, pregelatinized corn starch

Questions or comments?  call 844-508-1455, 8:00 am - 6:00 pm CT, Monday - Friday

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69584-012-10

EXTRA STRENGTH

ACETAMINOPHEN TABETS, USP


500 mg

Pain Reliever/Fever Reducer

100 TABLETS

OXFORD PHARMACEUTICALS, LLC

TAMPER EVIDENT: DO NOT USE IF THE FOIL INNER SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

PEEL BACK FOR DRUG FACTS

Manufactured by:
OXFORD PHARMACEUTICALS, LLC
BIRMINGHAM, AL 35211


8000010
Rev. 0118-00

NDC 69584-012-90

EXTRA STRENGTH

ACETAMINOPHEN TABETS, USP


500 mg

Pain Reliever/Fever Reducer

1000 TABLETS

OXFORD PHARMACEUTICALS, LLC

TAMPER EVIDENT: DO NOT USE IF THE FOIL INNER SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

PEEL BACK FOR DRUG FACTS

Manufactured by:
OXFORD PHARMACEUTICALS, LLC
BIRMINGHAM, AL 35211


8000011
Rev. 0118-00

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69584-012
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen500 mg
Inactive Ingredients
Ingredient NameStrength
Croscarmellose Sodium 
Hypromelloses 
Polyethylene Glycol, Unspecified 
Povidones 
Starch, Corn 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize12mm
FlavorImprint CodeO;12
Contains    
Packaging
#Item CodePackage Description
1NDC:69584-012-10100 TABLET in 1 BOTTLE
2NDC:69584-012-901000 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/25/2018
Labeler - Oxford Pharmaceuticals, LLC (079638266)
Establishment
NameAddressID/FEIOperations
Oxford Pharmaceuticals, LLC079638266manufacture(69584-012)

 
Oxford Pharmaceuticals, LLC

← See all Acetaminophen brands

Medically reviewed on Jan 23, 2018

Further information

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

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