Acetaminophen USP 325 mg Tablets

Acetaminophen USP 325 mg Tablets

Drug Labeling and Warnings

Drug Details

k">

ACETAMINOPHEN 325 MG- acetaminophen tablet 
Preferred Pharmaceuticals Inc.

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 USP 325 mg Tablets

Drug Facts

Active ingredient (in each tablet)

Acetaminophen USP, 325 mg

Purpose

Pain reliever/fever reducer

Uses

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

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

  • adult takes more than 4,000 mg in 24 hours, which is the maximum daily amount
  • child takes more than 5 tablets in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks 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.

Ask a doctor before use if the user has liver disease

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
  • pain gets worse or lasts more than 5 days in children
  • 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. 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 4-6 hours while symptoms last, not more than 12 tablets in 24 hours

children 6 to 11 years

take 1 tablet every 4-6 hours while symptoms last, not more than 5 tablets in 24 hours

children under 6 years

do not use

Other information

  • store at 15° to 30°C (59° to 86°F)

Inactive ingredients

povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid

Questions or comments?

call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Tylenol®.

Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

www.reliable1labs.com

Repackaged By: Preferred Pharmaceuticals Inc.

NDC: 68788-7245

Regular Strength

Acetaminophen USP 325 mg

PAIN RELIEVER

FEVER REDUCER

*Compare to Active Ingredient in Regular Strength TYLENOL®

Acetaminophen Tablets 325mg
ACETAMINOPHEN 325 MG 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68788-7245(NDC: 69618-010)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize8mm
FlavorImprint Code AP;012
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68788-7245-330 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/16/2018
2NDC: 68788-7245-660 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/16/2018
3NDC: 68788-7245-990 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/16/2018
4NDC: 68788-7245-1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/16/2018
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/16/2018
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals Inc.791119022REPACK(68788-7245)

Revised: 5/2019
 
Preferred Pharmaceuticals Inc.


© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.