Topco Associates LLC. Headache Relief Drug Facts
Active ingredients (in each geltab)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID*)
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Purposes
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:
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:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
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.
- •skin reddening
- •blisters
- •rash
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 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 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
Stop use and ask a doctor if
These could be signs of a serious condition
- •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 occur
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.
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). 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 of age 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.
Inactive ingredients
black iron oxide, carnauba wax, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, gelatin, glycerin, hypromellose, maltitol solution, medium-chain triglycerides, microcrystalline cellulose, pharmaceutical ink, polyvinyl acetate phthalate, povidone, pregelatinized starch, propylene glycol, stearic acid, titanium dioxide