Extra Strength Pain Relief (Acetaminophen) Tablet, Film Coated [Rite Aid Corporation] -

EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET, FILM COATED [RITE AID CORPORATION]
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NDC	11822-5311-2, 11822-5311-5
Set ID	00c121ff-141d-410b-8632-c884a3909552
Category	HUMAN OTC DRUG LABEL
Packager	Rite Aid Corporation
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:
  - headache
  - toothache
  - the common cold
  - muscular aches
  - backache
  - 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 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:
- 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 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 red #27 aluminum lake, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, polyethylene glycol, polyvinyl alcohol, povidone,
sodium starch glycolate*, stearic acid, sucralose, talc, titanium dioxide
*may contain this ingredient
Questions or comments?

1-800-426-9391
Principal display panel

Compare to the active ingredient of Extra Strength Tylenol® **

EXTRA STRENGTH PAIN RELIEF
ACETAMINOPHEN

ACETAMINOPHEN 500 mg
PAIN RELIEVER/FEVER REDUCER

contains no aspirin

100
COATED
TABLETS

ACTUAL SIZE

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

50844 REV1018B53112

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

DISTRIBUTED BY:
RITE AID, 30 HUNTER LANE
CAMP HILL, PA 17011
www.riteaid.com

SATISFACTION
GUARANTEE
If you're not satisfied, well
happily refund your money.

Rite Aid 44-531C

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH PAIN RELIEF
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-5311
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
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TALC (UNII: 7SEV7J4R1U)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11822-5311-5	1 in 1 CARTON	12/11/2005
1		50 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:11822-5311-2	1 in 1 CARTON	12/11/2005
2		100 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

Labeler - Rite Aid Corporation (014578892)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(11822-5311)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	pack(11822-5311)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(11822-5311)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	manufacture(11822-5311)

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Medic

EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET, FILM COATED [RITE AID CORPORATION]

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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