PHARBETOL- acetaminophen tablet 
A-S Medication Solutions

----------

Pharbetol Extra Stength Tablet

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
  • the common cold
  • headache
  • backache
  • minor pain of arthritis
  • toothache
  • muscular aches
  • premenstrual and menstrual cramps
  • temporarily reduces fever

Warnings

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

  • more than 4000 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
  • 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
  • redness or swelling is present
  • new symptoms occur

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 case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you don't notice any signs or symptoms.

Directions

  • do not take more than directed (see overdose warning).

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

children under 12 years

Ask a doctor

Other information

  • store between 20-250C (68-770F)

Inactive ingredients

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

Questions or comments?

(866)-562-2756 (Mon - Fri 8 AM to 4 PM EST)

HOW SUPPLIED

Product: 50090-0395

Acetaminophen

Label Image
PHARBETOL 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-0395(NDC:16103-376)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize12mm
FlavorImprint Code PH044
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50090-0395-82 in 1 BOTTLE; Type 0: Not a Combination Product07/24/201712/31/2023
2NDC:50090-0395-2100 in 1 BOTTLE; Type 0: Not a Combination Product11/28/201412/31/2023
3NDC:50090-0395-520 in 1 BOTTLE; Type 0: Not a Combination Product11/28/201412/31/2023
4NDC:50090-0395-015 in 1 BOTTLE; Type 0: Not a Combination Product11/28/201412/31/2023
5NDC:50090-0395-350 in 1 BOTTLE; Type 0: Not a Combination Product11/28/201412/31/2023
6NDC:50090-0395-424 in 1 BOTTLE; Type 0: Not a Combination Product11/28/201412/31/2023
7NDC:50090-0395-130 in 1 BOTTLE; Type 0: Not a Combination Product11/28/201412/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01/10/200612/31/2023
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-0395) , REPACK(50090-0395)

Revised: 9/2024
Document Id: 3e346053-953d-4f11-9a77-5cc80de40bf8
Set id: 722ea0b1-1455-443f-bed1-12daa43b71b4
Version: 22
Effective Time: 20240905
 
A-S Medication Solutions