APAP 500 MG Oral Tablet

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Drug Information

Imprint:	C;15
Shape:	C48336
Color:	C48325
Ingredients:	Acetaminophen
Size:	18.00
Score:	1
Rxtty:	SY
Author:	Cispharma, Inc
Inactive Ingredients:	CARNAUBA WAX / HYPROMELLOSE 2910 (5 MPA.S) / POLYETHYLENE GLYCOL / PROPYLENE GLYCOL / POVIDONE / STARCH, PREGELATINIZED CORN / STEARIC ACID / TITANIUM DIOXIDE>

Drug Facts

Active ingredient (in each caplet)

Acetaminophen .....................500 mg
PURPOSE

Pain Reliever/ Fever Reducer
Uses
Temporarily relieves minor aches and pains due to:
- headache
- the common cold
- backache
- muscular aches
- minor pain of arthritis
- toothache
- premenstrual and menstrual cramps
temporarily reduces fever
Warnings
Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers or fever reducers. Acetaminophen may cause liver damage.

Do not use with any other drug containing acetaminophen
Stop use and ask a doctor if
- 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
These could be signs of a serious condition.
Indicated for pain relief.

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 can cause serious health problems, including liver damage. In case of overdose, get medical help or contact poison control center right away. 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 as needed. do not take more than 8 caplets in 24 hours do not use more than 10 days unless directed by a doctor
children under 12 years	do not use this adult product in children under 12 years of age: this will provide more than the recommended dose (overdose) and may cause liver damage.

Other Information
- store between 20Â°- 25Â°C (68Â°- 77Â°F)
- do not use if the box is opened
Inactive Ingredients

Carnauba wax, hypromellose, polyethylene glycol, propylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide
SPL UNCLASSIFIED SECTION

This product is not manufactured or distributed by McNeil Consumer & Specialty Pharmaceuticals, distributor of TylenolÂ®

Questions or Comments?
Call 1-866-383-9908

Manufactured by:

Cispharma Inc
1212 Cranbury S River Road
Cranbury, NJ 08512
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACETAMINOPHENÂ
acetaminophen tablet

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

Ingredient Name	Strength
Inactive Ingredients
CARNAUBA WAX (UNII: R12CBM0EIZ)	Â
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)	Â
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)	Â
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	Â
POVIDONE (UNII: FZ989GH94E)	Â
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)	Â
STEARIC ACID (UNII: 4ELV7Z65AP)	Â
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)	Â

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52204-115-99	26549 in 1 DRUM

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	03/28/2011

Labeler -Â Cispharma, Inc (833171445)

Registrant -Â Cispharma, Inc (833171445)

Name	Address	ID/FEI	Business Operations
Establishment
Cispharma, Inc		833171445	manufacture