PHARBETOL REGULAR STRENGTH- acetaminophen tablet 
Pharbest Pharmaceuticals, Inc.

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Drug Facts

Active ingredient (in each tablet)

Acetaminophen 325mg

Purpose

Pain reliever/fever reducer

Uses

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children.

Severe liver damage may occur if

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
  • 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 in adults 
  • 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 the reach of children.

Overdose warning:

In the case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

adults and children 12 years and over                     
  • take 2 tablets, every 4 to 6 hours while symptoms last
  • do not take more than 10 tablets in 24 hours, unless directe by a doctor
  • do not use for more than 10 days unless directed by a doctor
children 6 to under 12 years
  • take 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours
  • do not use for more than 5 days unless directed by a doctor
children under 6 yearsask a doctor

Other information

Inactive ingredients

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

Questions?

Adverse drug event call: (866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

PHARBEST

NDC 16103-353-11

Manufactured in the USA

Regular Strength

*COMPARE TO the active ingredients in TYLENOL® REGULAR STRENGTH TABLETS

Contains no Aspirin

PHARBETOL®

Acetaminophen 325mg each

Pain Reliever • Fever Reducer

THIS PACKAGE FOR HOUSEHOLD WITHOUT YOUNG CHILDREN

1000 TABETS

Pharbetol 325 mg Tablet Package Label

PHARBETOL  REGULAR STRENGTH
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16103-353
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize10mm
FlavorImprint Code PH020
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16103-353-071 in 1 CARTON01/09/2007
160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:16103-353-081 in 1 CARTON01/09/2007
2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:16103-353-111000 in 1 BOTTLE; Type 0: Not a Combination Product01/09/2007
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01301/09/2007
Labeler - Pharbest Pharmaceuticals, Inc. (557054835)
Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
Establishment
NameAddressID/FEIBusiness Operations
Pharbest Pharmaceuticals, Inc.557054835analysis(16103-353) , manufacture(16103-353) , pack(16103-353) , label(16103-353)

Revised: 12/2024
Document Id: e9f070f5-6ad7-436f-a56a-0806991bcfde
Set id: e0a39957-d918-4125-88f9-0e550b976fa1
Version: 4
Effective Time: 20241231
 
Pharbest Pharmaceuticals, Inc.