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Medline Acetaminophen by Medline Industries, Inc.

Medically reviewed on November 29, 2017

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg
Labeler: Medline Industries, Inc.
NDC Code: 53329-642

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 325 mg Tablets

ACTIVE INGREDIENT (IN EACH TABLET)

Acetaminophen USP, 325 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. Severe liver damage may occur if:

  • adults take 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

If you are taking blood thinning drug warafin

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 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)

Age

Dose

Adults and children 12 years and over

  • Take 2 tablets every 4 to 6 hours while symptoms last
  • Do not take more than 12 tablets in 24 hours

Children 6-11 years

  • Take 1 tablet every 4 to 6 hours while symptoms last
  • Do not take more than 5 tablets in 24 hours

Children under 6 years

Do not use Regular Strength products in children under 6 years of age; this will provide more than recommended dose (overdose) of acetaminophen and may cause liver damage.

OTHER INFORMATION
  • store at room temperature

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 53329-642-30

Compare to the Active Ingredient in Extra Strength Tylenol®

ACETAMINOPHEN

Regular Strength Pain Reliever

PAIN RELIEVER

FEVER REDUCER

325 mg

100 tablets 325 mg each

Side Panel
MEDLINE ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-642
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONES 
PROPYLENE GLYCOL 
STEARIC ACID 
SODIUM STARCH GLYCOLATE TYPE A CORN 
STARCH, CORN 
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUND (ound flat faced beveled edge) Size12mm
FlavorImprint CodeGPI;A325;
Contains    
Packaging
#Item CodePackage Description
1NDC:53329-642-30100 TABLET in 1 BOTTLE
2NDC:53329-642-981000 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.

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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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