ACETAMINOPHEN- acetaminophen tablet
NCS HealthCare of KY, Inc dba Vangard Labs

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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Active Ingredient (in each caplet)

Acetaminophen 500mg

Purpose

Pain Reliever/Fever Reducer

Uses

for the temporary relief of minor aches and pains due to:

•Headache

•Muscular aches

• Backache

• Minor pain of arthritis

•The common cold

• Toothache

• Premenstrual and menstrual cramps

Temporarily reduces 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 non prescription). 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 Breastfeeding,

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 the 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

Do not take more than directed.

Adults and children 12 years and over:

• take 2 caplets every 4 to 6 hours while symptoms last

• do not take more than 8 caplets 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) of acetaminophen and may cause liver damage.

Other information

• Do not use if imprinted safety seal under cap is broken or missing.

• store at room temperature

Inactive ingredients

Hypromellose, Polyollytone Glycol, Providone, Pregelantinized Starch, Sodium Starch Glycolate, Stearlic Acid.

Questions?

Adverse Drug Event call (800) 616-2471

Principal Display Panel

Acetaminophen Caplets 500mg

See New Warnings Information

ACETAMINOPHEN
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0615-2542(NDC:0904-1983)
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (ACETAMINOPHEN)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSES
AMMONIUM LAURETH-5 SULFATE
POVIDONE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
12-HYDROXYSTEARIC ACID

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL (Oblong)	Size	18mm
Flavor		Imprint Code	GPI;45
Contains

Packaging
#	Item Code	Package Description
1	NDC:0615-2542-31	31 in 1 BLISTER PACK
2	NDC:0615-2542-39	30 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part343	05/04/2011

Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)

Establishment
Name	Address	ID/FEI	Business Operations
NCS HealthCare of KY, Inc dba Vangard Labs		050052943	RELABEL(0615-2542), REPACK(0615-2542)

Revised: 08/2012

Document Id: c7b6af44-666c-4aed-be5a-e9e8184b7905

Set id: 3e22bac6-4f08-4395-aab2-2ce8655c3dc5

Version: 5

Effective Time: 20120807

NCS HealthCare of KY, Inc dba Vangard Labs