Pain Reliever ACETAMINOPHEN IBUPROFEN CVS PHARMACY FDA Approved Uses • temporarily relieves minor aches and pains due to: • headache • toothache • backache • menstrual cramps • muscular aches • minor pain of arthritis
FunFoxMeds box
Substance Acetaminophen
Route
ORAL
Applications
ANDA214836

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each caplet) Acetaminophen 250 mg Ibuprofen 125 mg (NSAID*) *nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive ingredients colloidal silicon dioxide corn starch croscarmellose sodium crospovidone ferric oxide yellow microcrystalline cellulose polyethylene glycol polyvinyl alcohol povidone pregelatinized starch stearic acid sucralose talc titanium dioxide
Strengths
250 mg 125 mg
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Due To Headache Toothache Backache Menstrual Cramps Muscular Aches Minor Pain Of Arthritis
Pill Appearance
Shape: oval Color: yellow Imprint: I;I

Identifiers & Packaging

Container Type BOX
UNII
362O9ITL9D WK2XYI10QM
Packaging

Package/Label Principal Display Panel CVS ™ ACETAMINOPHEN + IBUPROFEN Dual Action PAIN RELIEVER Acetaminophen 250 mg & Ibuprofen (NSAID) 125 mg Tablets, Pain Reliever Compare to Advil ® Dual Action active ingredients 36 CAPLETS ‡ ‡ Capsule-Shaped Tablets CONTAINS 2 MEDICINES actual size cvs-pain-reliever-carton-image.jpg

Package Descriptions
  • Package/Label Principal Display Panel CVS ™ ACETAMINOPHEN + IBUPROFEN Dual Action PAIN RELIEVER Acetaminophen 250 mg & Ibuprofen (NSAID) 125 mg Tablets, Pain Reliever Compare to Advil ® Dual Action active ingredients 36 CAPLETS ‡ ‡ Capsule-Shaped Tablets CONTAINS 2 MEDICINES actual size cvs-pain-reliever-carton-image.jpg

Overview

Uses • temporarily relieves minor aches and pains due to: • headache • toothache • backache • menstrual cramps • muscular aches • minor pain of arthritis

Indications & Usage

Uses • temporarily relieves minor aches and pains due to: • headache • toothache • backache • menstrual cramps • muscular aches • minor pain of arthritis

Dosage & Administration

Directions • do not take more than directed Adults and children 12 years and over: take 2 caplets every 8 hours while symptoms persist Children under 12 years: ask a doctor • do not take more than 6 caplets in 24 hours, unless directed by a doctor

Warnings & Precautions
Warnings Acetaminophen liver damage warning: This product contains acetaminophen. Severe liver damage may occur if you take: • with other drugs containing acetaminophen • more than 6 caplets in 24 hours, which is the maximum daily amount for this product • 3 or more alcoholic drinks every day while using this product Acetaminophen allergy alert: may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If skin reaction occurs, stop use and seek medical help right away. NSAID allergy alert: ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: • hives • facial swelling • asthma (wheezing) • shock • skin reddening • rash • blisters If an allergic reaction occurs, stop use and seek medical help right away. NSAID 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 Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist • if you have ever had an allergic reaction to acetaminophen or any other pain reliever • right before or after heart surgery Ask a doctor before use if • you have liver disease • stomach bleeding warning applies to you • you have problems or serious side effects from taking pain relievers • you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke • you are taking a diuretic Ask a doctor or pharmacist before use if you are • under a doctor’s care for any serious condition • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin • taking any other drug When using this product • take with food or milk if stomach upset occurs Stop use and ask a doctor if • 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 • you have symptoms of heart problems or stroke: • chest pain • trouble breathing • weakness in one part or side of body • slurred speech • leg swelling • pain gets worse or lasts more than 10 days • redness or swelling is present in the painful area • any new symptoms appear If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen 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 (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Purpose

Purposes Pain reliever

Do Not Use

Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist • if you have ever had an allergic reaction to acetaminophen or any other pain reliever • right before or after heart surgery

When Using

When using this product • take with food or milk if stomach upset occurs

Stop Use & Ask a Doctor

Stop use and ask a doctor if • 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 • you have symptoms of heart problems or stroke: • chest pain • trouble breathing • weakness in one part or side of body • slurred speech • leg swelling • pain gets worse or lasts more than 10 days • redness or swelling is present in the painful area • any new symptoms appear

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). Prompt 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 • read all warnings and directions before use. Keep carton. • store at 20-25°C (68-77°F) • avoid excessive heat above 40°C (104°F)

Questions

Questions or comments? 1-800-719-9260


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