PHARBETOL- acetaminophen tablet

Pharbetol by

Drug Labeling and Warnings

Pharbetol by is a Otc medication manufactured, distributed, or labeled by A-S Medication Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Acetaminophen 500mg

Purpose

Pain reliever/fever reducer

Uses

Temporarily relieves minor aches and pains due to:headachebackacheminor pain of arthritistoothachemuscular achesmenstrual crampsTemporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you takemore than 8 tablets in 24 hours, which is the maximum daily amountwith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this product

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:

Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away.

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 8 tablets in 24 hours. Do not take for more than 10 days unless directed by a doctor.
• Children under 12 years: do not use adult extra strength product in children under 12 years of age; this will provide more than recommended dose (overdose) and may cause liver damage.
  

Inactive ingredients

Povidone, Pregelatinized corn starch, sodium starch glycolate, stearic acid.

Questions?

Adverse drug event call: (866) 562-2756

HOW SUPPLIED

Product: 50090-0395

NDC: 50090-0395-0 15 TABLET in a BOTTLE

NDC: 50090-0395-1 30 TABLET in a BOTTLE

NDC: 50090-0395-2 100 TABLET in a BOTTLE

NDC: 50090-0395-3 50 TABLET in a BOTTLE

NDC: 50090-0395-4 24 TABLET in a BOTTLE

NDC: 50090-0395-5 20 TABLET in a BOTTLE

NDC: 50090-0395-8 2 TABLET in a BOTTLE

Acetaminophen

INGREDIENTS AND APPEARANCE

PHARBETOL 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50090-0395(NDC:16103-376)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
POVIDONE K30 (UNII: U725QWY32X)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	PH044
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50090-0395-8	2 in 1 BOTTLE; Type 0: Not a Combination Product	07/24/2017
2	NDC: 50090-0395-2	100 in 1 BOTTLE; Type 0: Not a Combination Product	11/28/2014
3	NDC: 50090-0395-5	20 in 1 BOTTLE; Type 0: Not a Combination Product	11/28/2014
4	NDC: 50090-0395-0	15 in 1 BOTTLE; Type 0: Not a Combination Product	11/28/2014
5	NDC: 50090-0395-3	50 in 1 BOTTLE; Type 0: Not a Combination Product	11/28/2014
6	NDC: 50090-0395-4	24 in 1 BOTTLE; Type 0: Not a Combination Product	11/28/2014
7	NDC: 50090-0395-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	11/28/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	01/10/2006

Labeler - A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Business Operations
A-S Medication Solutions		830016429	RELABEL(50090-0395) , REPACK(50090-0395)