APAP- 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.

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1190

Drug Facts

Active Ingredient

(in each caplet)
Acetaminophen 500 mg

Purposes

Analgesic, Antipyretic

Uses

temporarily relieves minor aches and pains associated with
the common cold
headache
toothache
muscular aches
backache
minor pain of arthritis
premenstrual and 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

These 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 case of In case of overdose, get medical help or contact Poison Control Center right away. (1-800-222-1222) Quick 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. Do not take for more than 10 days unless directed by a doctor.
children under 12 years of age	Do not use Extra Strength product in children 12 years of age; this will provide more than the recommended dose (overdose) of pain reliever and may cause liver damage.

DO NOT EXCEED RECOMMENDED DOSE

Other information

store at room temperature, USP

Inactive Ingredients

Hypromellose, Mineral Oil, Polyethylene Glycol, Povidone, Pregelatinized Starch, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Stearic Acid and Titanium Dioxide.

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

Manufactured by:
CONTRACT PHARMACAL CORP.
135 Adams Avenue
Hauppauge, NY 11788 USA
www.CPCHealth.com
Rev. 01/09

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

b2cde99f-figure-01

APAP
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10267-1190
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
HYPROMELLOSES (UNII: 3NXW29V3WO)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K30 (UNII: U725QWY32X)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	OVAL (capsule-shaped)	Size	17mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10267-1190-6	50 in 1 BOTTLE; Type 0: Not a Combination Product	01/09/2001	08/31/2015
2	NDC:10267-1190-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/09/2001	08/31/2015
3	NDC:10267-1190-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	01/09/2001	08/31/2015
4	NDC:10267-1190-4	1000 in 1 BOTTLE; Type 0: Not a Combination Product	01/09/2001	08/31/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	01/09/2001	08/31/2015

Labeler - Contract Pharmacal Corp. (057795122)

Registrant - Contract Pharmacal Corp. (057795122)

Name	Address	ID/FEI	Business Operations
Establishment
Contract Pharmacal Corp		968334974	manufacture(10267-1190)

Revised: 10/2017

Document Id: 5be86e1a-7c39-8db7-e053-2a91aa0a81b0

Set id: a72fbd83-f8e5-4bbd-a6b2-8659621eb6b3

Version: 2

Effective Time: 20171019

Contract Pharmacal Corp.