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ACETAMINOPHEN by Preferred Pharmaceuticals, Inc.

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: Preferred Pharmaceuticals, Inc.
NDC Code: 68788-9399

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 500 mg

Purposes

Pain reliever/fever reducer

Uses
for the temporary relief of 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. The maximum daily dose of this product is 6 tablets (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 non prescription). 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: Taking more than the recommended dose (overdose) may cause liver damage. In the 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 tablets every 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.

Other information
Do not use if imprinted safety seal under cap is broken or missing.
Store at room temperature

Inactive ingredients

Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid

Questions?

If you have any questions or comments, or to report an adverse event, please contact 1 800-medline.

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ONDRA
PHARMACEUTICALS
See New Warnings Information and Directions

Extra Strength

Acetaminophen 500 mg
PAIN RELIEVER
FEVER REDUCER
CONTAINS NO ASPIRIN

Repackaged By: Preferred Pharmaceuticals Inc.

Compare to the Active Ingredient in Extra Strength Tylenol®

This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark of Extra Strength Tylenol®

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-9399(NDC:51645-602)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE, UNSPECIFIED 
STARCH, CORN 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUND (round flat faced beveled edge) Size12mm
FlavorImprint CodeGPI;A5
Contains    
Packaging
#Item CodePackage Description
1NDC:68788-9399-220 TABLET in 1 BOTTLE, PLASTIC
2NDC:68788-9399-330 TABLET in 1 BOTTLE, PLASTIC
3NDC:68788-9399-445 TABLET in 1 BOTTLE, PLASTIC
4NDC:68788-9399-550 TABLET in 1 BOTTLE, PLASTIC
5NDC:68788-9399-1100 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34306/16/2014
Labeler - Preferred Pharmaceuticals, Inc. (791119022)
Registrant - Preferred Pharmaceuticals, Inc. (791119022)
Establishment
NameAddressID/FEIOperations
Preferred Pharmaceuticals, Inc.791119022REPACK(68788-9399)

Revised: 08/2017
 
Preferred 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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