Active Ingredient (In Each Caplet)
| Active ingredient (in each caplet) | Purpose |
| Acetaminophen 250 mg | Pain reliever |
| Aspirin 250 mg (NSAID) *
nonsteroidal anti-inflammatory drug | Pain reliever |
| Caffeine 65 mg | Pain reliever aid |
Extra Strenght Headache Relief Tablet
FDA Label NDC 29485-6538
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lil' Drug Store Products, Inc. for the product Extra Strenght Headache Relief (NDC 29485-6538). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each caplet), purpose, uses, reye's syndrome, allergy alert, liver warning, stomach bleeding warning, caffeine warning, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever
Pain reliever
Pain reliever aid
Uses
temporarily relieves minor aches and pains due to:
- headache
- a cold
- arthritis
- muscular aches
- sinusitis
- toothache
- premenstrual & menstrual cramps
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
Aspirin may cause a severe allergic reaction which may include:
- hives
- facial swelling
- asthma (wheezing)
- shock
- skin reddening
- blisters
- rash
Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Liver Warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 caplets 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 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
- any other drug containing an NSAID (prescription or nonprescription)
- a prescription drug for diabetes, gout, or arthritis
- any other drug, or are under a doctor's care for any serious condition
- a blood thinning (anticoagulant) or steroid drug
Stop Use And Ask 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
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
Overdose Warning
In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. 1(800) 222-1222
Directions
- do not use more than directed (seeOVERDOSE WARNING)
- drink a full glass of water with each dose
- adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours
- children under 12 years: ask a doctor
Other Information
- Each caplet contains: Magnesium 0.58 mg
- store at controlled room temperature 20° - 25° C (68° - 77° F)
- read all product information before using. Keep this box for important information
Inactive Ingredients
colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, talc
Questions Or Comments
1-888-333-9792
Other
DISTRIBUTED BY 7-ELEVEN, INC.
Irving, TX 75063
WWW.7-ELEVEN.COM
Made in Korea
6 Count Carton
24/7 for Life By 7-ELEVEN
Extra Strength
Headache
Relief
Acetaminophen Aspirin ( NSAID)
and Caffeine
Pain Reliever/Fever Reducer
compare to EXCEDRIN®
EXTRA STRENGTH active ingredients
6 CAPLETS
* Please review the disclaimer below.
