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Medline Acetaminophen

Medically reviewed by Drugs.com. Last updated on Dec 9, 2019.

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: Medline Industries, Inc.
NDC Code: 53329-641

Medline Acetaminophen 500 mg Tablets

ACTIVE INGREDIENT (IN EACH CAPLET)

Acetaminophen USP, 500 mg

PURPOSE

Pain reliever/fever reducer

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

WARNINGS

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tables (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

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.
  • or more than 10 days for pain unless directed by a doctor ■ for more than 3 days for fever unless directed by a doctor
  • 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

If you are taking blood thinning drug warafin

Stop use and ask a doctor if
  • symptoms do not improve
  • or fever persists or gets worse
  • 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. 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 and children 12 years and over

▪ take 2 caplets every 6 hours while symptoms last
▪ do not take more than 6 caplets in 24 hoursunless 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 at room temperature
  • Do not use if imprinted safety seal under cap is broken or missing

INACTIVE INGREDIENTS

Povidone, Pregelatinzed Starch, Sodium Starch Glycolate, Searic Acid.

QUESTIONS?

If you have any questions or comments, or to report an adverse event, please contact 1-800-MEDLINE (633-5463)

PRINCIPAL DISPLAY PANEL

MEDLINE ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-641
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE 
PROPYLENE GLYCOL 
STEARIC ACID 
SODIUM STARCH GLYCOLATE TYPE A CORN 
STARCH, CORN 
Product Characteristics
Colorwhite (round flat faced beveled edge) Score2 pieces
ShapeROUNDSize12mm
FlavorImprint CodeGPI;A5
Contains    
Packaging
#Item CodePackage Description
1NDC:53329-641-30100 TABLET in 1 BOTTLE
2NDC:53329-641-981000 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34312/26/2013
Labeler - Medline Industries, Inc. (025460908)
Establishment
NameAddressID/FEIOperations
Gemini Pharmaceuticals, Inc. dba Plus Pharma055942270manufacture(53329-641)

 
Medline Industries, Inc.

Further information

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