Pain Reliever Extra Strength (Acetaminophen) Tablet, Film Coated [Chain Drug Consortium] -

PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]
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NDC	68016-636-10, 68016-636-50
Set ID	f29705e5-2cdb-44d9-bea9-6cffb745a423
Category	HUMAN OTC DRUG LABEL
Packager	Chain Drug Consortium
Generic Name
Product Class
Product Number
Application Number	PART343

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Active ingredient (in each tablet)

Acetaminophen 500 mg
Purpose

Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- backache
- muscular aches
- headache
- the common cold
- toothache
- minor pain of arthritis
- premenstrual and menstrual cramps
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- blisters
- rash
- skin reddening
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
- with any other drug 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 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 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.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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
- adults and children 12 years and over
- take 2 tablets every 6 hours while symptoms last
- do not take more than 6 tablets 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
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive ingredients

corn starch, D&C yellow #10 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide
Questions or comments?

1-800-426-9391
Principal Display Panel

Premier
Value®

NDC 68016-636-10

*COMPARE TO THE ACTIVE INGREDIENT IN
EXTRA STRENGTH TYLENOL®

Extra Strength
Pain Reliever
Acetaminophen 500 mg
PAIN RELIEVER/FEVER REDUCER

100 Tablets

Non aspirin
Easy to swallow

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

Distributed By:
Pharmacy Value Alliance, LLC
407 East Lancaster Avenue,
Wayne, PA 19087
www.emersongroup.com

*This product is not manufactured or
distributed by McNeil Consumer Healthcare,
owner of the registered trademark Extra
Strength Tylenol®. 50844 REV0816A53112

PV
Independently Tested
Satisfaction Guaranteed

If for any reason you are not satisfied with
this product, please return it to the store
where purchased for a full refund.

Premier Value 44-531A

INGREDIENTS AND APPEARANCE

PAIN RELIEVER EXTRA STRENGTH
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68016-636
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
STARCH, CORN (UNII: O8232NY3SJ)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
TALC (UNII: 7SEV7J4R1U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	RED	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	44;531
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68016-636-10	1 in 1 CARTON	12/11/2005	02/04/2023
1		100 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:68016-636-50	1 in 1 CARTON	12/11/2005	02/04/2023
2		50 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part343	12/11/2005	02/04/2023

Labeler - Chain Drug Consortium (101668460)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(68016-636)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	MANUFACTURE(68016-636)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	PACK(68016-636)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	PACK(68016-636)

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Medic

PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

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