APAP EXTRA STRENGTH- acetaminophen tablet
Contract Pharmacal Corp

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.

----------

0546

Drug Facts

Active Ingredient

(in each tablet)
Acetaminophen 500 mg

Purposes

Analgesic, Antipyretic

Uses

temporarily relieves minor aches and pains associated with
the common cold
headache
toothache
muscular aches
backache
arthritis
menstrual cramps
reduction of 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/fever reducers. Acetaminophen may cause liver damage.

Do not use

if you are taking other acetaminophen products

Stop use and ask a doctor if

new symptoms occur
redness or swelling is present
pain gets worse or lasts for more than 10 days
fever gets worse or lasts more than 3 days

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

adults and children 12 years of age and over	take 2 tablets every 4 hour to 6 hours, not to exceed 8 tablets in 24 hours
children under 12 years of age	Do not use this adult strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of pain reliever and could cause serious health problems.

DO NOT EXCEED RECOMMENDED DOSE

Other information

store at 20˚ - 25˚C (68˚-77˚F); excursions to 15˚ - 30˚C (59˚ - 86˚F).

Inactive Ingredients

Polyvinylpyrrolidone Pregelatinized Starch, Sodium Starch Glycolate and Stearic Acid.

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

Manufactured by: CONTRACT PHARMACAL CORP.
Hauppauge, NY 11788 USA www.CPCHealth.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

APAP EXTRA STRENGTH
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10267-0546
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
POVIDONE K30 (UNII: U725QWY32X)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	12mm
Flavor		Imprint Code	CPC;546
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10267-0546-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/17/2001	12/31/2012
2	NDC:10267-0546-4	1000 in 1 BOTTLE; Type 0: Not a Combination Product	01/17/2001	12/31/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	01/17/2001	12/31/2012

Labeler - Contract Pharmacal Corp (057795122)

Registrant - Contract Pharmacal Corp (057795122)

Name	Address	ID/FEI	Business Operations
Establishment
Contract Pharmacal Corp		968334974	manufacture(10267-0546)

Revised: 10/2017

Document Id: 5bc23769-8769-d4cf-e053-2a91aa0a4b69

Set id: 19b4b6b4-bd5f-41ba-ab56-c53ee4ebe178

Version: 2

Effective Time: 20171017

Contract Pharmacal Corp