basic care migraine relief ACETAMINOPHEN ASPIRIN CAFFEINE AMAZON.COM SERVICES LLC FDA Approved Use • treats migraine
FunFoxMeds box
Substance Acetaminophen
Route
ORAL
Applications
ANDA075794
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each geltab) Acetaminophen 250 mg Aspirin 250 mg (NSAID*) Caffeine 65 mg *nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive ingredients black iron oxide carnauba wax crospovidone D&C yellow #10 aluminum lake FD&C blue #1 aluminum lake gelatin glycerin hypromellose maltitol solution medium-chain triglycerides microcrystalline cellulose pharmaceutical ink polyvinyl acetate phthalate povidone pregelatinized starch propylene glycol stearic acid titanium dioxide Questions or comments? 1-800-719-9260
Strengths
250 mg 65 mg
Treats Conditions
Use Treats Migraine
Pill Appearance
Shape: round Color: green Imprint: M

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
362O9ITL9D R16CO5Y76E 3G6A5W338E
Packaging

Package/Label Principal Display Panel amazon basic care Treats Migraine Compare to Excedrin ® Migraine active ingredients Migraine Relief Acetaminophen/Aspirin (NSAID)/Caffeine Tablets Pain Reliever/Pain Reliever Aid actual size 80 GELTABS** **Gelatin Coated Tablets 2z5-bn-migraine-relief

Package Descriptions
  • Package/Label Principal Display Panel amazon basic care Treats Migraine Compare to Excedrin ® Migraine active ingredients Migraine Relief Acetaminophen/Aspirin (NSAID)/Caffeine Tablets Pain Reliever/Pain Reliever Aid actual size 80 GELTABS** **Gelatin Coated Tablets 2z5-bn-migraine-relief

Overview

Use • treats migraine

Indications & Usage

Use • treats migraine

Dosage & Administration

Directions • do not use more than directed • adults: take 2 geltabs with a glass of water • if symptoms persist or worsen, ask your doctor • do not take more than 2 geltabs in 24 hours, unless directed by a doctor • under 18 years of age: as a doctor

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: 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. 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 2 geltabs 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 Medication overuse headache warning: Headaches may worsen if this product is used for 10 or more days per month. 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 severe 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 never had migraines diagnosed by a health professional • you have a headache that is different from your usual migraines • you have the worst headache of your life • you have fever and stiff neck • you have headaches beginning after or caused by head injury, exertion, coughing or bending • you experienced your first headache after the age of 50 • you have daily headaches • you have a migraine so severe as to require bed rest • 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 • you have problems or serious side effects from taking pain relievers or fever reducers • you have vomiting with migraine headache Ask a doctor or pharmacist before use if you are • taking a prescription drug for: • diabetes • gout • arthritis • under a doctor’s care for any serious condition • taking any other drug • taking any other product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer 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 • your migraine is not relieved or worsens after first dose • new or unexpected symptoms occur • ringing in the ears or loss of hearing occurs 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.
Purpose

Purposes Pain reliever Pain reliever aid

Do Not Use

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

Stop Use & Ask a Doctor

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 • your migraine is not relieved or worsens after first dose • new or unexpected symptoms occur • ringing in the ears or loss of hearing occurs

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. (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.

Questions

Questions or comments? 1-800-719-9260


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