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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APAP - 0220

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Drug Facts

Active Ingredient

(in each tablet)
Acetaminophen 325 mg

Purposes

Analgesic
Antipyretic

Uses

temporarily relieves minor aches and pains due to
the common cold
headache
toothache
muscular aches
backache
minor pain of arthritis
menstrual cramps
temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

adults take more than 12 tablets in 24 hours, which is the maximum daily amount
child take more than 5 doses in 24 hours
taken with other drugs containing acetaminophen
adult has 3 or more alcoholic drinks every day while using this product

Do not use

with any other product containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist
if you are allergic to acetaminophen or any other inactive ingredients in this products

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

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

Manufactured by:
Contract Pharmacal Corp.
Hauppauge, NY 11788 USA
www.CPCHealth.com
Rev. 05/10

Drug Facts (continued)

Stop use and ask a doctor if

pain gets worse or lasts for more than 10 days in adults and children
pain gets worse or lasts for more than 5 days in children under 12 years
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 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 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

Do not take more than directed (see overdose warning).

adults and children 12 years of age and over	take 2 tablets every 4 to 6 hours; not to exceed 12 tablets in 24 hours
children 6-11 years of age	take 1 tablets every 4 to 6 hours; not to exceed 5 tablets in 24 hours
children under 6 years of age	Do not use adult Regular Strength product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

DO NOT EXCEED RECOMMENDED DOSE

Other information

store at controlled room temperature, USP
side effects occur. You may report side effects to the FDA at 1-800-FDA-1088 (Toll Free).

Inactive ingredients

Polyvinylpyrrolodone, Pregelatinized Starch, Sodium Starch Glycolate and Stearic Acid.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

APAP
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10267-0220
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE K30 (UNII: U725QWY32X)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	10mm
Flavor		Imprint Code	CPC;220
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10267-0220-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/29/2001	06/30/2012
2	NDC:10267-0220-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	05/29/2001	06/30/2012
3	NDC:10267-0220-4	1000 in 1 BOTTLE; Type 0: Not a Combination Product	05/29/2001	06/30/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	05/29/2001	06/30/2012

Labeler - Contract Pharmacal Corp (057795122)

Name	Address	ID/FEI	Business Operations
Establishment
Contract Pharmacal Corp		968334974	manufacture(10267-0220)

Revised: 10/2017

Document Id: 5bc174ed-3c73-dd45-e053-2a91aa0a8846

Set id: 608604f3-ff05-4958-be02-c3a7725ee2e6

Version: 3

Effective Time: 20171017

Contract Pharmacal Corp