ACETAMINOPHEN ES- pharbetol tablet

Acetaminophen ES by

Drug Labeling and Warnings

Acetaminophen ES by is a Otc medication manufactured, distributed, or labeled by Contract Pharmacy Services-PA, Coupler Enterprises Inc.. 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:

• 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 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

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 and ask doctor before use 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 pregant or breast-feeding, ask doctor before use.

Keep out of reach of children.

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.
  

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.

Inactive ingredients

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

Questions?

Adverse drug event call: (866) 562-2756

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN ES 
pharbetol tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67046-028(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: 67046-028-30	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	01/10/2006
2	NDC: 67046-028-60	60 in 1 BLISTER PACK; Type 0: Not a Combination Product	01/10/2006
3	NDC: 67046-028-62	60 in 1 BLISTER PACK; Type 0: Not a Combination Product	01/10/2006

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

Labeler - Contract Pharmacy Services-PA (945429777)

Establishment
Name	Address	ID/FEI	Business Operations
Coupler Enterprises Inc.		945429777	repack(67046-028)