PHARBETOL REGULAR STRENGTH- acetaminophen tablet

Pharbetol by

Drug Labeling and Warnings

Pharbetol by is a Otc medication manufactured, distributed, or labeled by Pharbest Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (per tablet)

Acetaminophen 325mg

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
  • menstrual cramps
• Temporarily reduces fever

Warnings

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

• Adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
• Child takes more than 5 doses in 24 hours
• Taken with other drugs containing acetaminophen
• Adult has 3 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 in adults and children
• 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 sign of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of the reach of children.

Overdose warning:

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

Directions

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

• Adults and children 12 years and over: Take 2 tablets every 4 to 6 while symptoms last.; Do not take more than 12 tablets in 24 hours.
• Children 6 to under 12 years: Take 1 tablet every 4 to 6 while symptoms last.; Do not take more than 5 tablets in 24 hours.
• Children under 6 years: Do not use adult regular strength products in childern under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Other information

• Tamper Evident: do not use if imprinted safety seal under cap is broken or missing
• store between 20-25°C (68-77°F)
• use by expiration date on package
  

Inactive ingredients:

Povidone, pregelatinized starch, sodium starch glycolate, stearic acid.

Questions?

Adverse drug event call: (866) 562-2756

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PHARBETOL  REGULAR STRENGTH
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16103-353
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
POVIDONES (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	PH020
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 16103-353-07	1 in 1 CARTON
1		60 in 1 BOTTLE, PLASTIC
2	NDC: 16103-353-08	1 in 1 CARTON
2		100 in 1 BOTTLE, PLASTIC
3	NDC: 16103-353-11	1000 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	01/09/2007

Labeler - Pharbest Pharmaceuticals, Inc. (557054835)

Establishment
Name	Address	ID/FEI	Business Operations
Pharbest Pharmaceuticals, Inc.		557054835	manufacture(16103-353) , pack(16103-353) , label(16103-353)