PHARBETOL- acetaminophen tablet

Pharbetol by

Drug Labeling and Warnings

Pharbetol by is a Otc medication manufactured, distributed, or labeled by ATLANTIC BIOLOGICALS CORP., UNIT DOSE SOLUTIONS. 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

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

PRINCIPAL DISPLAY PANEL

NDC: 17856-0376-01

PHARBETOL

Acetaminophen 500mg

Pain Reliever Fever Reducer

100 TABLETS

INGREDIENTS AND APPEARANCE

PHARBETOL 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17856-0376(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: 17856-0376-1	100 in 1 BOX, UNIT-DOSE	09/08/2022
1	NDC: 17856-0376-2	1 in 1 POUCH; Type 0: Not a Combination Product

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

Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)

Registrant - ATLANTIC BIOLOGICALS CORP. (047437707)

Establishment
Name	Address	ID/FEI	Business Operations
UNIT DOSE SOLUTIONS		360804194	repack(17856-0376)