PHARBETOL- acetaminophen 500mg tablet, coated 
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 caplet)

Acetaminophen 500mg

Purpose

Pain Reliever/fever reducer

Uses

Warnings

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

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

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
  • 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:

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

Directions

Other information

Inactive ingredients

hypromellose, povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid, talc, triacetin

Questions?

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

PHARBEST

NDC 16103-350-11

Manufactured in the USA

Extra Strength *COMPARE TO the active ingredient in EXTRA STRENGTH TYLENOL® CAPLETS

Do not use with any other product containing acetaminophen

PHARBETOL

Acetaminophen 500 mg

Pain Reliever • Fever Reducer

1000 CAPLETS

Pharbetol 500 mg Caplet Product Label Image

PHARBETOL 
acetaminophen 500mg tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16103-350
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULE (Capsule Shaped Tablet (Caplet)) Size18mm
FlavorImprint Code PH016
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16103-350-041 in 1 CARTON03/01/2018
130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:16103-350-081 in 1 CARTON03/01/2018
2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:16103-350-10500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2018
4NDC:16103-350-111000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/01/2018
Labeler - Pharbest Pharmaceuticals, Inc. (557054835)
Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
Establishment
NameAddressID/FEIBusiness Operations
Pharbest Pharmaceuticals, Inc.557054835manufacture(16103-350) , label(16103-350) , pack(16103-350)

Revised: 3/2018
Document Id: d1bd1da4-872b-4a51-b888-3fa8ff30448e
Set id: 27337be9-e279-460e-903e-ae4463099599
Version: 1
Effective Time: 20180301
 
Pharbest Pharmaceuticals, Inc.