Acetaminophen Aspirin Caffeine ACETAMINOPHEN ASPIRIN CAFFEINE WALGREEN CO FDA Approved Use treats migraine
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Substance Acetaminophen
Route
ORAL
Applications
ANDA214039

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each caplet) Acetaminophen 250 mg Aspirin 250 mg (NSAID)** Caffeine 65 mg **nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive ingredients carnauba wax hydroxypropyl cellulose hypromellose microcrystalline cellulose polyethylene glycol sodium stearyl fumarate and titanium dioxide
Strengths
250 mg 65 mg
Treats Conditions
Use Treats Migraine
Pill Appearance
Shape: capsule Color: white Imprint: I1

Identifiers & Packaging

Container Type UNKNOWN
UNII
362O9ITL9D R16CO5Y76E 3G6A5W338E
Packaging

Principal Display Panel 24ct

Package Descriptions
  • Principal Display Panel 24ct

Overview

Use treats migraine

Indications & Usage

Use treats migraine

Dosage & Administration

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

Warnings & Precautions
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 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 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 nervousness, irritability, sleeplessness and occasionally rapid heart beat.
Purpose

Purposes Pain reliever 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 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Storage & Handling

Other information ■ store at room temperature 20° to 25°C (68° to 77°F) ■ close cap tightly after use ■ read all product information before using.

Questions

Questions or comments? Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.


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