Extra Strength Headache Relief

SUPERVALU INC.

Equaline 44-159B

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients (in each tablet)
• Purpose
• Extra Strength Headache Relief Uses
• Warnings
  • Do not use
  • Ask a doctor before use if
  • 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.
• Directions
• Extra Strength Headache Relief Other information
• Inactive ingredients
• Questions or comments?
• Principal display panel

FULL PRESCRIBING INFORMATION

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

Extra Strength Headache Relief 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 reovering from chicken pox or flu-like symptoms should not use this product.  When using this product, if changes in behavior with nausea 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.  Sever liver 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:

• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• are age 60 or older
• take other drugs containing prescription or nonprescription NSAIDs [aspirin, 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, occasionally, 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 nonprescription).  If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 

Ask a doctor before use if

• stomach bleeding warning applies to you
• you have a history of stomach problems, such as heartburn
• you have liver idease
• you have high blood pressure, heart disease, liver disease or kidney disease
• you have asthma
• you are taking a diuertic

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 bloddy 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 more than 10 days
• painful area is red or swollen
• fever gets worse or lasts more than 3 days 

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 beause 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 eveni f you do not notice any signs or symptoms.

Directions

• do not use more than directed
• drink a full 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 

Extra Strength Headache Relief 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, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide 

Questions or comments?

1-877-932-7948 

Principal display panel

equaline

compare to Extra Strength Excedrin® active ingredients**

NDC 41163-159-08

extra strength
headache relief

acetaminophen, aspirin (NSAID)
and caffeine

pain reliever/pain reliever aid

24 coated tablets

DOES NOT CONTAIN GLUTEN

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

50844    REV1011A15908

DISTRIBUTED BY SUPERVALU INC.
EDEN PRARITE, MN 55344 USA

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