Pain Reliever Extra Strength (Acetaminophen) Tablet [L.n.k. International, Inc.] -

PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]
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NDC	50844-519-02, 50844-519-15
Set ID	72babe91-2586-4f05-ae90-6debfd23aa5d
Category	HUMAN OTC DRUG LABEL
Packager	L.N.K. International, Inc.
Generic Name
Product Class
Product Number
Application Number	PART343

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Active ingredient (in each gelcap)

Acetaminophen 500 mg
Purpose

Pain reliever / fever reducer
Uses
- temporarily relieves minor aches and pains due to:
  - headache
  - backache
  - toothache
  - the common cold
  - minor pain of arthritis
  - muscular aches
  - 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 of acetaminophen in 24 hours
- 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:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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 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 gelcaps every 6 hours while symptoms last
  - do not take more than 6 gelcaps 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- avoid high humidity
- see end flap for expiration date and lot number
Inactive ingredients

croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide
Questions or comments?

1-800-426-9391
Principal Display Panel

QUALITY
PLUS

NDC 50844-519-02

*Compare to active ingredient in Extra Strength Tylenol® Rapid Release Gels

EXTRA STRENGTH
PAIN RELIEVER
Acetaminophen 500 mg
PAIN RELIEVER/FEVER REDUCER

RAPID RELEASE

12 Gelcaps                                    Actual Size

CONTAINS NO ASPIRIN

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

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Extra Strength Tylenol® Rapid Release Gels.

Distributed by LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788
USA                  50844    REV0417E51902

44-519

INGREDIENTS AND APPEARANCE

PAIN RELIEVER EXTRA STRENGTH
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50844-519
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
HYPROMELLOSES (UNII: 3NXW29V3WO)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)
SHELLAC (UNII: 46N107B71O)

Product Characteristics
Color	RED, BLUE	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	L;5
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50844-519-15	1 in 1 CARTON	05/10/2004
1		50 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:50844-519-02	1 in 1 CARTON	05/10/2004
2		12 in 1 BOTTLE, PLASTIC; 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	05/10/2004

Labeler - L.N.K. International, Inc. (038154464)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(50844-519)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	MANUFACTURE(50844-519) , PACK(50844-519)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	PACK(50844-519)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	PACK(50844-519)

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Medic

PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]

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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