Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet, coated 
New World Imports, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Acteminophen 500 mg

Pain reliever / Fever reducer

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.

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

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.

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.

Corn Starch, Hydroxypropyl Methylcellulose, Pregelatinized Starch, Propylene Glycol, Stearic Acid, Titanium Dioxide.  May contain providone and sodium starch glycolates

ACETAMINOPHEN  EXTRA STRENGTH
acetaminophen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51824-012
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)
HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)
Propylene Glycol (UNII: 6DC9Q167V3)
Stearic Acid (UNII: 4ELV7Z65AP)
Titanium Dioxide (UNII: 15FIX9V2JP)
Povidone (UNII: FZ989GH94E)
Sodium Starch Glycolate Type A Potato (UNII: 5856J3G2A2)

Product Characteristics
Color	white (White)	Score	no score
Shape	OVAL (Oval)	Size	18mm
Flavor		Imprint Code	AZ;012
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51824-012-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/14/2010	08/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	09/14/2010	08/01/2019

Labeler - New World Imports, Inc (075372276)

Revised: 8/2017

Document Id: c8ef867b-4f84-4f37-8b77-6df5dc506de1

34390-5

Set id: c1a8cb8b-b95d-429d-88db-4bffc219c8a4

Version: 3

Effective Time: 20170808