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Drug Labeling and Warnings

Drug Details

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REGULAR STRENGTH PAIN RELIEF- 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.

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Active Ingredients

Acetaminophen 325 mg

Purpose

Pain Reliever/Fever Reducer

Uses

  • temporarily relieves minor aches and pains
  • temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen.
The maximum daily dose of this product is 10 tablets
in 24 hours. Severe liver damage may occur if you take:

  • more than 12 tablets (4,000 mg of acetaminophen)

in 24 hours

  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day 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 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 symptom 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. 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
  • adults and children 12 years and over: take 2 tablets every 4-6 hours, as needed; not more than 10 tablets in 24 hours
  • children under 12 years: ask a doctor

Other Information

  • store at 20⁰C-25⁰C (68⁰F-77⁰F)

Inactive Ingredients

povidone, sodium starch glycolate, starch stearic acid.

Package Label

Gericare

NDC: 68788-7359

Regular Strength

ACETAMINOPHEN

Pain Reliever / Fever Reducer

*Compare to active ingredient in the Regular Strength Tylenol tablets

package not child resistant

325 mg each

Dist. by: Gericare Pharmaceuticals Corp.

1650 63rd street

Brooklyn, NY 11204

Repackaged by Preferred Pharmaceuticals, Inc.

Acetaminophen Tablets 325mg
REGULAR STRENGTH PAIN RELIEF 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68788-7359(NDC: 57896-102)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize10mm
FlavorImprint Code GC101
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68788-7359-330 in 1 BOTTLE; Type 0: Not a Combination Product08/21/2019
2NDC: 68788-7359-660 in 1 BOTTLE; Type 0: Not a Combination Product08/21/2019
3NDC: 68788-7359-990 in 1 BOTTLE; Type 0: Not a Combination Product08/21/2019
4NDC: 68788-7359-1100 in 1 BOTTLE; Type 0: Not a Combination Product08/21/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/21/2019
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals Inc.791119022REPACK(68788-7359)

Revised: 8/2019
 
Preferred Pharmaceuticals Inc.


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