EXTRA STRENGTH ACETAMINOPHEN tablet

Extra Strength Acetaminophen by

Drug Labeling and Warnings

Extra Strength Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Contract Pharmacy Services-PA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

ACTIVE INGREDIENT (IN EACH CAPLET)

Acetaminophen Caplets, 500 mg

PURPOSE

Pain reliever/fever reducer

USES

• temporarily reduces fever
• temporarily relieves minor aches and pains due to:
  1. headache
  2. muscular aches
  3. the common cold
  4. minor pain of arthritis
  5. backache
  6. toothache
  7. premenstrual and menstrual cramps

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 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: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DIRECTIONS

• adults 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

OTHER INFORMATION

store at 15° to 30°C (59° to 86°F)

INACTIVE INGREDIENTS

povidone, pregelatinized starch, stearic acid

QUESTIONS OR COMMENTS?

Distributed by: Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, U.S.A.

call toll free 734-743-6000

Repackaged by:

Contract Pharmacy Services-PA
125 Titus Ave Suite 200
Warrington, PA 18976 USA

Original--08/2010--NJW

Package Label

500 mg Tablets

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH ACETAMINOPHEN 
extra strength acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67046-026(NDC:0904-1983)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL ((capsule-shaped))	Size	17mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67046-026-30	30 in 1 BLISTER PACK
2	NDC: 67046-026-60	60 in 1 BLISTER PACK
3	NDC: 67046-026-62	60 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	08/02/2010

Labeler - Contract Pharmacy Services-PA (945429777)