Active ingredient

Acetaminophen 500 mg

Purpose

Analgesic/Antipyretic

Uses

temporary relief of minor aches and pains associated with common cold headache toothache
muscular aches backache arthritis menstrual cramps and reduction of fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you takemore than 4000 mg of acetaminophen in 24 hours 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 or breast-feeding

ask a health professional before use

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.
Do not exceed recommended dosage.

Directions

Adults and children 12 years of age and older: Take 2 tablets (1,000 mg) every 6 hours while symptoms last. Do not take more than 6 tablets (3,000 mg) in 24 hours, unless directed by a doctor.

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 Ingredients

corn starch, hydroxypropyl methylcellulose, polyethylene glycol, pregelatinized starch, stearic acid, titanium dioxide. May contain povidone, and sodium starch glycolate.

Package/Label Principal Display Panel

$Z:\SPL-OTC Mono\Allegiant Health\Acetaminophen 500 mg Coated Tablet\LB0205.jpg$

PAIN RELIEF EXTRA STRENGTH
acetaminophen 500 mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69168-235
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
May contain	POVIDONES (UNII: FZ989GH94E)
May contain	SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	AZ235
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69168-235-50	50 in 1 BOTTLE; Type 0: Not a Combination Product	12/17/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	12/17/2014

Labeler - Allegiant Health (079501930)

Registrant - Allegiant Health (079501930)

Name	Address	ID/FEI	Business Operations
Establishment
Allegiant Health		079501930	ANALYSIS(69168-235) , LABEL(69168-235) , MANUFACTURE(69168-235) , PACK(69168-235) , RELABEL(69168-235) , REPACK(69168-235)

Drug Facts