PHARBETOL- acetaminophen tablet

Pharbetol by

Drug Labeling and Warnings

Pharbetol by is a Otc medication manufactured, distributed, or labeled by Proficient Rx LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 8 tablets in 24 hours, which is the maximum daily amount
• 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 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).

• 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

• Tamper Evident: do not use if imprinted safety seal under cap is broken or missing
• store between 20-250C (68-770F)

Inactive ingredients

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

Questions?

Adverse drug event call: 1-866-562-2756 Mon - Fri: 8 AM to 4 PM

PRINCIPAL DISPLAY PANEL

Repackaged By:

Proficient Rx LP

Thousand Oaks, CA 91320

NDC: 71205-478-50

manufactured in the USA

Extra Strength *Compare to the active ingredient in Extra Strength Tylenol® Caplet

Do not use with any other product containing acetaminophen

PHARBETOL

Acetaminophen 500mg

Pain Reliever Fever Reducer

50 TABLETS

INGREDIENTS AND APPEARANCE

PHARBETOL 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71205-478(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, UNSPECIFIED (UNII: FZ989GH94E)
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: 71205-478-20	20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/26/2024
2	NDC: 71205-478-24	24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/30/2020
3	NDC: 71205-478-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/30/2020
4	NDC: 71205-478-40	40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/12/2020
5	NDC: 71205-478-50	50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/12/2020
6	NDC: 71205-478-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/30/2020
7	NDC: 71205-478-90	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	01/10/2006

Labeler - Proficient Rx LP (079196022)

Establishment
Name	Address	ID/FEI	Business Operations
Proficient Rx LP		079196022	REPACK(71205-478) , RELABEL(71205-478)