FDA Label for Gencare Headache Relief

Active Ingredients  (In Each Caplet)

Acetaminophen 250 mg

Aspirin 250 mg
Caffeine 65 mg

Purpose

Acetaminophen 250 mg............................................................Pain reliever
Aspirin 250 mg (NSAID*)..........................................................Pain reliever
Caffeine 65 mg ..................................................................Pain reliever aid
(*nonsteroidal anti-inflammatory drug)

Uses:

temporarily relieves minor aches and pains due to:

•headache
•a cold
•arthritis
•muscular aches
•toothache
•premenstrual & 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 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: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.

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

•hives
•facial swelling
•asthma (wheezing)
•shock

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

•more than 8 caplets 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
•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)
•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 heart beat.

Do not use

•if you have ever had an allergic reaction to acetaminophen, 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 Doctor:

Ask a doctor before use if

•you have liver disease
•stomach bleeding warning applies 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 are taking a diuretic
•you have asthma

Ask Doctor/Pharmacist:

Ask a doctor or pharmacist before use if you are taking

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

Pregnancy

If pregnant or breast-feeding,ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in
pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during
delivery.

Directions

■ do not use more than directed

■ drink a full glass of water with each dose

■ adults and children 12 years of age and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours
■ children under 12 years: ask a doctor

Other Information

■ Store between 20°-25°C (68°-77°F)
■ Close cap tightly after use

■ Read all product information before using.
■ Keep this box for important information.

Inactive Ingredients

Microcrystalline cellulose, Pregelatinized starch, Stearic acid, Colloidal silicon dioxide, Magnesium stearate, croscarmellose sodium, PVK-K30, Sodium starch glycolate, Hydroxy propyl methyl cellulose, Polyethylene glycol, Talc, Titanium dioxide.

Questions Or Comments?

Call +1-(732)-994-2808 or email [email protected]