FDA Label for Tension Headache Aspirin-free
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH CAPLET)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- 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?
- PRINCIPAL DISPLAY PANEL
Tension Headache Aspirin-free Product Label
The following document was submitted to the FDA by the labeler of this product Rite Aid Corporation. 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 Caplet)
Acetaminophen 500 mg
(formulated with 65 mg caffeine)
Purpose
Pain reliever
Uses
- temporarily relieves minor aches and pains due to:
- headache
- muscular aches
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- 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
- blisters
- rash
- skin reddening
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
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 heartbeat.
Do Not Use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you are allergic to acetaminophen
Ask A Doctor Before Use If You Have
liver disease.
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin.
Stop Use And Ask A Doctor If
- new symptoms occur
- painful area is red or swollen
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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
- adults and children12 years and over: take 2 caplets every 6 hours. Do not take more than 6 caplets in 24 hours.
- children under 12 years: ask a doctor
Other Information
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive Ingredients
corn starch, crospovidone, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, talc, titanium dioxide
Questions Or Comments?
1-800-426-9391
Principal Display Panel
RITE AID®
PHARMACY
*Compare to the active ingredients in Excedrin® Tension Headache
tension headache
pain reliever
acetaminophen 500 mg
caffeine 65 mg
pain reliever
aspirin free
100 COATED CAPLETS
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by GSK group of companies, owner of the registered trademark Excedrin® Tension Headache.
50844 REV0417C42812
DISTRIBUTED BY: RITE AID
30 HUNTER LANE
CAMP HILL, PA 17011
SATISFACTION RITE AID GUARANTEE - IF YOU'RE NOT SATISFIED, WE'LL HAPPILY REFUND YOUR MONEY.
* Please review the disclaimer below.