FDA Label for Extra Strength Headache Relief

Otc - Purpose

* nonsteroidal anti-inflammatory drug

Use

temporarily relieves minor aches and pains due to:

backache
headaches
colds
muscular aches
minor arthritis pain
menstrual cramps
Temporarily reduces fever.

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 behaviour 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
• asthma (wheezing)
• shock


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.

Liver Warning

This product contains acetaminophen. Severe 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 (perscription or nonperscription). If you are not sure wether a drug contains acetaminophen, ask a doctor or pharmacist.
• 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
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
• take more or for a longer time than directed
• have 3 or more alcoholic drinks every day while using this product

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, iritability, sleeplessness, and occasionally rapid heart beat.

Do Not Use

• if you are allergic to aspirin or any other pain reliever / fever reducer
• with any other pain reliever/fever reducer
• for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor
• if you have ever had an allergic reaction to any other pain reliever-fever reducer
• with any other product containing acetaminophen this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns

Ask A Doctor Before Using If:

• you have liver disease
• the stomach bleeding warning applies to you
• you have a history of stomach problems (such as heartburn, upset stomach or stomach pain) 
• you have high blood pressure, heart, liver 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

• anticoagulation (thinning of blood)
• diabetes
• gout
• arthritis

When using this product do not exceed recommended dose.

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Stop Use And Ask A Doctor If:

• an allergic reaction occurs. Seek medical help right away.
• ringing in the ears or loss of hearing occurs
• pain or fever persists or gets worse
• new symptoms occur
• redness or swelling is present
• you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding.

Otc - Pregnancy Or Breast Feeding

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 SPECIFICALLY DIRECTED TO DO SO BY A DOCTOR BECAUSE IT MAY CAUSE PROBLEMS IN THE UNBORN CHILD OR COMPLICATIONS DURING DELIVERY.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away(1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• adults and children 12 years of age and older:
  2 tablets as needed for pain every 6 hours.
  Do not exceed 8 tablets in 24 hours or as directed by a doctor.
• children under 12 years: consult a doctor

Other Information

• TAMPER EVIDENT. DO NOT USE IF PACKET IS TORN, CUT OR OPENED
• store at controlled room temperature 15°-30°C (59°-86°F)
• avoid excessive heat and humidity

Inactive Ingredients

Hydroxypropyl Methylcellulose*, Maltodextrin*, Microcrystalline Cellulose, Polyethylene Glycol*, Povidone, Sodium Starch Glycolate, Starch, Stearic Acid, Titanium Dioxide*

*contains one or more of these ingredients

Questions Or Comments?

1-844-428-2538

Other

Manufactured by Ultratab Laboratories, Inc

Repackaged and distributed by
Convenience Valet^®, Glendale Heights, IL 60139