EXTRA STRENGTH HEADACHE RELIEF - acetaminophen, aspirin and caffeine tablet, film coated
DOLGENCORP, LLC

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Rexall 44-159

Active ingredient(s)

Acetaminophen 250 mg

Aspiring 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Pain reliever aid

Use(s)

temporarily relieves minor aches and pains due to:
headache
a cold
arthritis
muscular aches
sinusitis
toothache
premenstrual and menstrual cramps

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with naussea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction, which may include:

hives
facial swelling
shock
asthma (wheezing)

Liver warning: This product contains acetaminophen. Severe lliver damage may occur if you take:

more than 8 tablets 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

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

are age 60 or older
hae had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription or nonprescription NSAIDs [aspiring, ibuprofen, naproxen or others]
have 3 or more alcoholic drinks every day while using this product
take more or for a longer time than directed

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionaly, rapid heartbeat.

Do not use

if you ever had an allergic reaction to aspirin or any other pain reliever/fever reducer
with any other drug containing acetaminophen (prescription or non prescription). 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
stomach bleeding warning appies to you
you have a history of stomach problems, such as heartburn
you have high blood pressure, heart disease, liver cirrhosis or kidney disease

Ask a doctor or pharmacist before use if you are

taking a prescription drug for diabetes, gout, or arthritis
taking any other drug or are under a doctor's care for any serious condition

Stop use and ask a doctor if

you experience any of the following signs of stomach bleeding:
feel faint
have bloody or black stools
vomit blood
have stomach pain that does not get better
an allergic reaction occurs. Seek medical help right away.
any new symptoms appear
ringing in the ears or loss of hearing occurs
pain gets worse or lasts for more than 10 days
fever gets worse or lasts for more than 3 days
painful area is red or swollen

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

do not use more than directed
drink a full glass of water with each dose
adults and children 12 years and over
take 2 tablets every 6 hours
do not take more than 8 tablets in 24 hours
children under 12 years: do not use unless directed by a doctor

Other information

store at controlled room temperature 15º-30ºC (59º-86ºF)
see end flap for expiration date and lot number

Inactive ingredients

corn starch, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, shellac wax, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide

Principal Display Panel

The product packaging shown below representa a sample of that currently in use. Additional packaging may also be available.

Since 1903

Rexall®

EXTRA STRENGTH

HEADACHE RELIEF

Acetaminophen 250 mg,

Aspiring 250 mg (NSAID), caffeine 65 mg

Pain Reliever / Pain Reliever Aid

SEE NEW WARNINGS INFORMATION

50 Coated Tablets

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

50844 REV 0810A15915

Visit us at: Rexall.com

or call 1-866-4-REXALL

MANUACTURED FOR DOLGENCORP, LLC

100 MISSIONS RIDGE

GOODLETTSVILLE, TN 37072 USA

Product Packaging

EXTRA STRENGTH HEADACHE RELIEF
acetaminophen, aspirin and caffeine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	55910-159
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (ACETAMINOPHEN)	ACETAMINOPHEN	250 mg
ASPIRIN (ASPIRIN)	ASPIRIN	250 mg
CAFFEINE (CAFFEINE)	CAFFEINE	65 mg

Inactive Ingredients
Ingredient Name	Strength
CROSPOVIDONE
HYPROMELLOSES
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
POVIDONE
PROPYLENE GLYCOL
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
TITANIUM DIOXIDE

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	13mm
Flavor		Imprint Code	44;159
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	55910-159-15	1 BOTTLE In 1 CARTON	contains a BOTTLE, PLASTIC
1		50 TABLET In 1 BOTTLE, PLASTIC	This package is contained within the CARTON (55910-159-15)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	11/17/1992

Labeler - DOLGENCORP, LLC (068331990)

Revised: 02/2011DOLGENCORP, LLC