Extra Strength Headache Relief
FDA Label NDC 79481-0062
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Meijer, Inc. for the product Extra Strength Headache Relief (NDC 79481-0062). 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 drug facts, active ingredients (in each caplet)acetaminophen 250 mgaspirin 250 mg (nsaid)* caffeine 65 mg *nonsteroidal anti-inflammatory drug, purposespain relieverpain reliever pain reliever aid, uses temporarily relieves minor aches and pains due to: ■ headache ■ a cold ■ arthritis ■ muscular aches ■ toothache ■ premenstrual & menstrual cramps, warningsreye’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 if a skin reaction occurs, stop use and seek medical help right way. allergy alert:aspirin may cause a severe allergic reaction which may include: ■ hives ■ facial swelling ■ asthma (wheezing) ■ shock 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 a nonsteroidal anti-inflammatory drug (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 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients (In Each Caplet)Acetaminophen 250 Mgaspirin 250 Mg (Nsaid)* Caffeine 65 Mg *Nonsteroidal Anti-Inflammatory Drug
Purposespain Relieverpain Reliever Pain Reliever Aid
Uses Temporarily Relieves Minor Aches And Pains Due To: ■ Headache ■ A Cold ■ Arthritis ■ Muscular Aches ■ Toothache ■ Premenstrual & Menstrual Cramps
Warningsreye’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 If A Skin Reaction Occurs, Stop Use And Seek Medical Help Right Way. Allergy Alert:Aspirin May Cause A Severe Allergic Reaction Which May Include: ■ Hives ■ Facial Swelling ■ Asthma (Wheezing) ■ Shock 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 A Nonsteroidal Anti-Inflammatory Drug (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 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 Appear These Could Be Signs Of A Serious Condition
If Pregnant Or Breast-Feedingask 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 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 ■ Store Between 20º - 25º C (68º - 77º F)
Inactive Ingredients Colloidal Silicon Dioxide, Hypromellose, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Pregelatinized Starch, Stearic Acid, Talc
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