ACETAMINOPHEN - acetaminophen tablet
Gemini Pharmaceuticals, Inc. dba ONDRA Pharmaceuticals

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 Ingredients

Acetaminophen 500 mg

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 warnings: This product contains acetaminophen. The maximum daily dose of this product is 6 caplets(3000 mg) in 24 hours.sever liver damage may occur if you take

more than 4000 mg of acetaminophen caplets 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 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 appear
redness or swelling is present This 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 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 (see overdose warning)

Adults and children 12 years and over:

take 2 caplets every 6 hours while symptoms last
do not take more than 6 caplets in 24 hours unless directed by a doctor
do not take for more than 10 days unless directed by a doctor

children under 12 years: ask a doctor

Other information

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

store at room temperature

povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions or comments?

If you have any questions or comments ,or to report an adverse event, please contact 1-800 medline.

Principal Display Panel

ONDRA PHARMACEUTICALS
See New Warning Information and Directions

Extra Strength

Acetaminophen 500 mg
PAIN RELIEVER
FEVER REDUCER
CONTAINS NO ASPIRIN

Compare to Active ingredient in Extra Strength Tylenol®

This product is not manufactured or distributed by McNeil Consumer Healthcare,Owner of the registered trademark Extra Strength Tylenol®

1000 CAPLETS
500mg each

ACETAMINOPHEN
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51645-601
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
POVIDONE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE (Capsule shaped Tablet)	Size	18mm
Flavor		Imprint Code	GP325
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:51645-601-10	1000 TABLET ( TABLET) in 1 BOTTLE, PLASTIC	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	04/04/2012

Labeler - Gemini Pharmaceuticals, Inc. dba ONDRA Pharmaceuticals (055942270)

Registrant - Gemini Pharmaceuticals, Inc. dba ONDRA Pharmaceuticals (055942270)

Establishment
Name	Address	ID/FEI	Operations
Gemini Pharmaceuticals, Inc. dba ONDRA Pharmaceuticals		055942270	manufacture

Revised: 04/2012 Gemini Pharmaceuticals, Inc. dba ONDRA Pharmaceuticals