ACETAMINOPHEN ASPIRIN AND CAFFEINE ACETAMINOPHEN ASPIRIN AND CAFFEINE BETTER LIVING BRANDS, LLC FDA Approved Use treats migraine
FunFoxMeds bottle
Substance Acetaminophen
Route
ORAL
Applications
ANDA211695

Drug Facts

Composition & Profile

Active Ingredients
Drug Facts Active ingredients (in each tablet) Acetaminophen USP 250 mg Aspirin USP 250 mg (NSAID*) Caffeine USP 65 mg *nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive ingredients crospovidone glyceryl monostearate low-substituted hydroxypropyl cellulose microcrystalline cellulose polyvinyl alcohol povidone pregelatinized starch (maize) sodium lauryl sulfate stearic acid talc and titanium dioxide.
Strengths
250 mg 65 mg
Quantities
24 tablets 100 tablets 8 tablets
Treats Conditions
Use Treats Migraine
Pill Appearance
Shape: capsule Color: white Imprint: T;57

Identifiers & Packaging

Container Type BOTTLE
UNII
362O9ITL9D R16CO5Y76E 3G6A5W338E
Packaging

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/250 mg/65 mg Container Label - 24 Tablets Signature NDC 21130-074-07 Care ® Quality Guaranteed Migraine Relief Acetaminophen, Aspirin (NSAID) and Caffeine Tablets USP 250 mg/250 mg/65 mg Pain Reliever/Pain Reliever Aid 24 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/250 mg/65 mg Container Label - 100 Tablets; PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/250 mg/65 mg Container Carton Label - 24 Tablets Signature Care ® Quality Guaranteed Do not use if seal imprinted with SEALED for YOUR PROTECTION under the bottle cap is broken or missing. Compare to the active ingredients of Excedrin ® Migraine Relief ** NDC 21130-074-07 Migraine Relief Acetaminophen, Aapirin (NSAID) and Caffeine Tablets USP 250 mg/250 mg/65 mg Actual Size Pain Reliever/Pain Reliever Aid 24 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/250 mg/65 mg Container Carton Label - 8 Tablets

Package Descriptions
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/250 mg/65 mg Container Label - 24 Tablets Signature NDC 21130-074-07 Care ® Quality Guaranteed Migraine Relief Acetaminophen, Aspirin (NSAID) and Caffeine Tablets USP 250 mg/250 mg/65 mg Pain Reliever/Pain Reliever Aid 24 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/250 mg/65 mg Container Label - 100 Tablets
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/250 mg/65 mg Container Carton Label - 24 Tablets Signature Care ® Quality Guaranteed Do not use if seal imprinted with SEALED for YOUR PROTECTION under the bottle cap is broken or missing. Compare to the active ingredients of Excedrin ® Migraine Relief ** NDC 21130-074-07 Migraine Relief Acetaminophen, Aapirin (NSAID) and Caffeine Tablets USP 250 mg/250 mg/65 mg Actual Size Pain Reliever/Pain Reliever Aid 24 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/250 mg/65 mg Container Carton Label - 8 Tablets

Overview

Use treats migraine

Indications & Usage

Use treats migraine

Dosage & Administration

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

Storage & Handling

Other information store at controlled room temperature 20°-25°C (68°-77°F) close cap tightly after use read all product information before using. Keep this box for important information.

Questions

Questions or comments? call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) DISTRIBUTED BY: BETTER LIVING BRANDS LLC P.O.BOX 99, PLEASANTON, CA 94566-0009 ‡ 1-888-723-3929 Made in India Code: AP/DRUGS/04/2016


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