MedLeaflet

HEADACHE RELIEF EXTRA STRENGTH

ACETAMINOPHEN, ASPIRIN AND CAFFEINE

Over the CounterORAL

Manufacturer: Salado Sales, Inc.

Clinical information

Indications & Usage

Uses temporarily relieves minor aches and pains due to: headache arthritis a cold toothache muscular aches premenstrual and menstrual cramps

Dosage & Administration

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

Safety

Warnings & Precautions

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: Aspirin may cause a severe allergic reaction which may include: shock facial swelling hives asthma (wheezing) 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 away. 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: 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 heartbeat. 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 you have liver disease you have asthma 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 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 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 more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present any new symptoms appear 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. 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.

Additional information

Storage & Handling

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

Frequently Asked Questions

What is the recommended dosage for Headache Relief Extra Strength?+

The recommended dosage for Headache Relief Extra Strength is 1-2 tablets every 6 hours as needed, not to exceed 8 tablets in 24 hours. It's essential to follow the dosage instructions carefully to avoid overdose. Consult a doctor if you have any questions or concerns about the dosage.

Can I take Headache Relief Extra Strength with other medications?+

It's generally not recommended to take Headache Relief Extra Strength with other medications, especially those containing acetaminophen, aspirin, or caffeine, as this can increase the risk of adverse effects. Certain medications, such as blood thinners, may interact with Headache Relief Extra Strength. Consult a doctor before taking this medication with other prescription or over-the-counter medications.

Is Headache Relief Extra Strength safe for people with stomach problems?+

Headache Relief Extra Strength contains aspirin, which can irritate the stomach and worsen conditions like ulcers or acid reflux. If you have a history of stomach problems, you should use this medication with caution and consider alternative pain relief options. Consult a doctor to discuss the potential risks and benefits of taking Headache Relief Extra Strength.

Can I take Headache Relief Extra Strength if I'm pregnant or breastfeeding?+

Aspirin and caffeine in Headache Relief Extra Strength may not be suitable for pregnant or breastfeeding women, as they can affect the fetus or baby. Acetaminophen is generally considered safe, but it's still crucial to consult a doctor before taking any medication during pregnancy or breastfeeding to discuss the potential risks and benefits. Consult a doctor for personalized advice on pain relief during pregnancy or breastfeeding.

How long can I take Headache Relief Extra Strength for chronic pain?+

Headache Relief Extra Strength is intended for temporary relief of minor aches and pains, and long-term use can lead to adverse effects like stomach ulcers or liver damage. If you experience chronic pain, it's essential to consult a doctor to discuss alternative treatment options and develop a plan for managing your pain. Consult a doctor to determine the best course of treatment for your specific condition.

MEDICAL DISCLAIMER

MedLeaflet provides information sourced directly from the FDA openFDA API. This is NOT professional medical advice and should not replace consultation with a licensed healthcare provider. Do not use this site to self-diagnose or self-medicate. Always consult your doctor or pharmacist before starting, stopping, or changing any medication.