FDA Label for Headache Relief, Extra Strength 24/7 Life By 7-eleven
View Indications, Usage & Precautions
- DRUG FACTS
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- REYE’S SYNDROME
- ALLERGY ALERT
- LIVER WARNING
- STOMACH BLEEDING WARNING
- CAFFEINE WARNING
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF
- 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
- HEADACHE RELIEF, EXTRA STRENGTH, 24-7 LIFE BY 7-ELEVEN TM - PDP/PACKAGE/LABEL
Headache Relief, Extra Strength 24/7 Life By 7-eleven Product Label
The following document was submitted to the FDA by the labeler of this product Lil' Drug Store Products, Inc.. 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.
Drug Facts
Drug Facts
Active Ingredients
Active ingredients (in each caplet)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID*)
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Purpose
Purpose
Pain reliever
Pain reliever
Pain reliever aid
Uses
Uses
temporarily relieves minor aches and pains due to:
- a cold
- toothache
- arthritis
- muscular aches
- headache
- premenstrual and menstrual cramps
Warnings
Warnings
Reye’S Syndrome
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
Allergy alert: Aspirin may cause a severe allergic reaction, which may include:
- hives
- facial swelling
- shock
- asthma (wheezing)
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Liver Warning
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
Stomach Bleeding Warning
Stomach bleeding warning:
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- have 3 or more alcoholic drinks every day while using this product
- are age 60 or older
- take more or for a longer time than directed
Caffeine Warning
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
Do not use
- if you have ever had an allergic reaction to 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
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 are taking a diuretic
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you have asthma
Ask A Doctor Or Pharmacist Before Use If
Ask a doctor or pharmacist before use if you are
- taking a prescription drug for diabetes, gout, or arthritis
Stop Use And Ask A Doctor If
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
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
- redness or swelling is present
- any new symptoms appear
If Pregnant Or Breast-Feeding
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
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center 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
Directions
- do not take more than directed
- drink a full glass of water with each dose
- adults and children 12 years and over: take 2 caplets every 6 hours. Do not take more than 8 caplets in 24 hours.
- children under 12 years: ask a doctor
Other Information
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
Inactive ingredients
corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch
glycolate, stearic acid, titanium dioxide
Questions Or Comments
Questions or comments?1-877-507-6516
Headache Relief, Extra Strength, 24-7 Life By 7-Eleven Tm - Pdp/Package/Label
Extra Strength, 24/7 Life by 7-Eleven TM
Extra Strength
Headache Relief
Acetaminophen,
Aspirin
(NSAID), Caffeine
Pain Reliever/Pain Reliever Aid
compare to
EXCEDRIN
®
EXTRA STRENGTH
HEADACHE
active ingredients
†
24
CAPLETS
Actual Size
[caplet image]
* Please review the disclaimer below.