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Medline Acetaminophen by Medline Industries, Inc.

Medically reviewed on Nov 29, 2017

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: Medline Industries, Inc.
NDC Code: 53329-640

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.

Medline Acetaminophen 500 mg Caplets

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

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

If you are taking blood thinning drug warafin

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 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 hours unless 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

NDC 53329-640-98

Compare to the Active Ingredient in Extra Strength Tylenol®

ACETAMINOPHEN

Extra Strength Pain Reliever

PAIN RELIEVER

FEVER REDUCER

500 mg

1000 Caplets* – 500 mg each

(*capsule-shaped tablet)

MEDLINE ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-640
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONES 
PROPYLENE GLYCOL 
STEARIC ACID 
SODIUM STARCH GLYCOLATE TYPE A CORN 
STARCH, CORN 
Product Characteristics
ColorwhiteScoreno score
ShapeOVAL (Capsule Shaped Tablet) Size18mm
FlavorImprint CodeGPI;A5;
Contains    
Packaging
#Item CodePackage Description
1NDC:53329-640-981000 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)

 
Medline Industries, Inc.

← See all Medline Acetaminophen brands

Further information

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

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