FDA Label for Basic Care Headache Relief
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH GELTAB)
- PURPOSES
- 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
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Basic Care Headache Relief Product Label
The following document was submitted to the FDA by the labeler of this product Amazon.com Services 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 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:
• skin reddening• blisters• rash• hives• facial swelling• asthma (wheezing)• shock• more than 4,000 mg of acetaminophen in 24 hours• with other drugs containing acetaminophen• 3 or more alcoholic drinks every day while using this product• 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
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.
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
• 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 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 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
Questions Or Comments?
1-800-719-9260
Package/Label Principal Display Panel
Extra Strength
Compare to Excedrin® Extra Strength active ingredients
Headache Relief
Acetaminophen/Aspirin (NSAID)/Caffeine
Pain Reliever/Pain Reliever Aid
80 GELTABS
actual size
* Please review the disclaimer below.