PHARBETOL REGULAR STRENGTH- acetaminophen tablet 
Pharbest 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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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 not finalpart34301/09/2007
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: 6/2023
Document Id: f0009efc-d00c-4da1-a47b-0500372bb313
Set id: e0a39957-d918-4125-88f9-0e550b976fa1
Version: 3
Effective Time: 20230613
 
Pharbest Pharmaceuticals, Inc.