PHARBETOL- acetaminophen 500mg tablet, coated

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 (in each caplet)

Acetaminophen 500mg

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 8 caplets 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
• 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

• do not take more than directed (see overdose warning)
  • adults and children 12 years and over:
    • take 2 caplets, every 6 hours while symptoms last
    • do not take more than 6 caplets in 24 hours, unless directed by a doctor
    • do not take for more than 10 days unless directed by a doctor
  • children under 12 years:

    ask a doctor

Other information

• Tamper Evident: do not use if imprinted safety seal under cap is broken or missing
• store between 20o-25oC (68o-77oF)

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

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

PHARBETOL 
acetaminophen 500mg tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16103-350
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
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
Color	white	Score	no score
Shape	CAPSULE (Capsule Shaped Tablet (Caplet))	Size	18mm
Flavor		Imprint Code	PH016
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 16103-350-04	1 in 1 CARTON	03/01/2018
1		30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 16103-350-08	1 in 1 CARTON	03/01/2018
2		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 16103-350-10	500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/01/2018
4	NDC: 16103-350-11	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	03/01/2018

Labeler - Pharbest Pharmaceuticals, Inc. (557054835)

Registrant - Pharbest Pharmaceuticals, Inc. (557054835)

Establishment
Name	Address	ID/FEI	Business Operations
Pharbest Pharmaceuticals, Inc.		557054835	manufacture(16103-350) , label(16103-350) , pack(16103-350)