ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by New World Imports, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Acteminophen 500 mg

PURPOSE

Pain reliever / Fever reducer

KEEP OUT OF REACH OF CHILDREN

In case of accidental overdose, contact a doctor or Poison Control Center immediately.  Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

INDICATIONS & USAGE

Temporary relief of minor aches and pains associated with: common cold, headache, toothache, muscular  aches, backache, arthritis, menstrual cramps, and reduction in fever.

WARNINGS

Liver Warning:This product contains acetaminophen. Severe liver damage may occur if you take:

-more than 8 caplets 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.

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:

-Symptoms do not improve

-Pain gets worse or lasts for more than 10 days

-Fever gets worse or lasts for more than 3 days

-New symptoms occur

-Redness or swelling is present

-A rare sensitivity reaction occurs

-You may report side effects to 1-888-952-0050

If pregnant of breast-feeding, ask a health professional before use.

Do not exceed recommended dosage.

DOSAGE & ADMINISTRATION

Adults and children 12 years of age and older: Take 2 caplets every 4 to 6 hours as needed.  Do not take more than 8 caplets in 24 hours.

Children under 12 years of age: Do not use this extra strength product.  This will provide more than the recommended dose (overdose) and could cause serious health problems.

INACTIVE INGREDIENT

Corn Starch, Pregelatinized Starch, Stearic Acid. May also contain prvidone and sodium starch glycolate

Label

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN  EXTRA STRENGTH
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51824-011
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
Starch, Corn (UNII: O8232NY3SJ)
Stearic Acid (UNII: 4ELV7Z65AP)
Povidone (UNII: FZ989GH94E)
Sodium starch glycolate Type A potato (UNII: 5856J3G2A2)

Product Characteristics
Color	white (White)	Score	no score
Shape	ROUND (round)	Size	12mm
Flavor		Imprint Code	AZ;011
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51824-011-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/14/2010	08/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	09/14/2010	08/01/2020

Labeler - New World Imports, Inc (075372276)