PHARBETOL- acetaminophen 500mg tablet, coated 
A-S Medication Solutions

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

HOW SUPPLIED

Product: 50090-1191

NDC: 50090-1191-0 40 TABLET, COATED in a BOTTLE

Acetaminophen 500mg

Label Image
PHARBETOL 
acetaminophen 500mg tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-1191(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:50090-1191-040 in 1 BOTTLE; 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 - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-1191) , REPACK(50090-1191)

Revised: 6/2019
Document Id: 8cd7dffe-2621-4b26-b679-4bb7ae028434
Set id: 622b3838-9ecf-481d-bf4b-4ca0ffa77492
Version: 1
Effective Time: 20190624
 
A-S Medication Solutions