Acetaminophen

Dosage form: tablet
Ingredients: Acetaminophen 325mg
Labeler: Preferred Pharmaceuticals, Inc
NDC Code: 68788-0775

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.

ACETAMINOPHEN
TABLETS USP
325 mg
PAIN RELIEVER/FEVER REDUCER

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Uses

to reduce fever and for the temporary relief of minor aches and pains due to

  • headache
  • backache
  • the common cold
  • premenstrual and menstrual cramps
  • muscular aches
  • minor pain of arthritis
  • toothache

Temporarily reduces fever.

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if

  • adult takes 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 everyday while using this product

Ask a doctor before use if the user has liver disease.

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.

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin.

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

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.

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 to 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 yearsDo not use adult regular strength products in children under 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.

Other information
  • TAMPER-EVIDENT: Each tablet is individually sealed. Do not use if blister is torn or broken.
  • store at controlled room temperature 15° - 30°C (59° - 86°F)
  • protect from moisture, heat and light

Inactive ingredients

povidone, starch, stearic acid

Questions?

call 1-888-838-2872, weekdays, 8 AM - 5 PM Eastern Time

This unit dose package is not child-resistant. If dispensed for outpatient use, a child-resistant container should be utilized.

Manufactured for:
GOLDLINE LABORATORIES, INC.
Sellersville, PA 18960
by: LNK International, Inc.
Hauppauge, NY 11788
0609REV 05 99-391
Repackaged by Preferred Pharmaceuticals, Inc
Anaheim, CA 92870

PRINCIPAL DISPLAY PANEL

NDC 68788-0775

ACETAMINOPHEN TABLET USP 325 mg

Repackaged By;
Preferred Pharmaceuticals, Inc
ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-0775(NDC:0182-8447)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen325 mg
Inactive Ingredients
Ingredient NameStrength
povidone 
stearic acid 
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUND (Bisect with flat face and beveled edge) Size10mm
FlavorImprint Code 44;104
Contains    
Packaging
#Item CodePackage Description
1NDC:68788-0775-220 TABLET (TABLET) in 1 BOTTLE
2NDC:68788-0775-330 TABLET (TABLET) in 1 BOTTLE
3NDC:68788-0775-660 TABLET (TABLET) in 1 BOTTLE
4NDC:68788-0775-990 TABLET (TABLET) in 1 BOTTLE
5NDC:68788-0775-1100 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34301/01/1993
Labeler - Preferred Pharmaceuticals, Inc (791119022)
Establishment
NameAddressID/FEIOperations
Preferred Pharmaceuticals, Inc791119022repack, relabel

Revised: 03/2011
 
Preferred Pharmaceuticals, Inc

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.

Hide
(web1)