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

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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Leader 44-159B

Active ingredients (in each tablet)

Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever
Pain reliever
Pain reliever aid

Uses

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
you have asthma
you are taking a diuretic

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 (1-800-222-1222) 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: ask a doctor

Other information

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
see end flap for expiration date and lot number

Inactive ingredients

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

Principal Display Panel

NDC 49781-065-51

Compare to Extra Strength Excedrin® active ingredients†

LEADER®

EXTRA STRENGTH
Headache Relief
Acetaminophen, Aspirin (NSAID) and Caffeine
Pain Reliever / Pain Reliever Aid

100 TABLETS

†This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Excedrin® Extra Strength.
50844 ORG071315912

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
CIN 4935821
www.myleader.com
1-800-200-6313

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

Leader 44-159B

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

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:37205-669
Route of Administration	ORAL	DEA Schedule

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

Ingredient Name	Strength
Inactive Ingredients
CROSPOVIDONE
HYPROMELLOSES
CELLULOSE, MICROCRYSTALLINE
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

#	Item Code	Package Description
Packaging
1	NDC:37205-669-78	1 in 1 CARTON
1		100 in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part343	11/17/1992	06/19/2014

Labeler - CARDINAL HEALTH (097537435)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(37205-669)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	MANUFACTURE(37205-669)

Revised: 6/2014

Document Id: 7eca7d6d-0600-41fa-835b-876e1c4264b1

Set id: fa3b7e30-85ae-4f31-911f-6b446e31c892

Version: 3

Effective Time: 20140619

CARDINAL HEALTH