FDA Label for Gencare Headache Relief
View Indications, Usage & Precautions
Gencare Headache Relief Product Label
The following document was submitted to the FDA by the labeler of this product Pioneer Life Sciences, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Acetaminophen 250 mg
Caffeine 65 mg
Aspirin 250 mg
Purpose
Pain reliever
Pain reliever
Pain reliever aid
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 geltabs 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 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.
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 geltabs every 6 hours; not more than 8 geltabs in 24 hours
•children under 12 years: ask a doctor
Other Information
•store at 20°-25°C (68°-77°F)
•close cap tightly after use
•read all product information before using. Keep this box for important information.
Questions Or Comments?
Call 1-732-698-5070 Monday through Friday 9AM–5PM EST or www.pioneerlifesciences.com
Inactive Ingredients
pregelatinized starch, povidone, stearic acid powder, hypromellose, microcrystalline cellulose, colloidol sillicon dioxide, polyethylene glycol, talc
Stop Use And Ask A Doctor If
•an allergic reaction occurs. Seek medical help right away.
•you experience any of the following signs of stomach bleeding:
•feel faint
•vomit blood
•have bloody or black stools
•have stomach pain that does not get better
•ringing in the ears or loss of hearing occurs
•painful area is red or swollen
•pain gets worse or lasts for more than 10 days
•fever gets worse or lasts for more than 3 days
•any new symptoms appear
These could be signs of a serious condition.
* Please review the disclaimer below.