ADVIL DUAL ACTION WITH ACETAMINOPHEN IBUPROFEN ACETAMINOPHEN NAVAJO MANUFACTURING COMPANY INC. FDA Approved Uses temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps muscular aches minor pain of arthritis
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Substance Acetaminophen
Route
ORAL
Applications
NDA211733

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each caplet) Purposes Acetaminophen 250 mg Pain reliever Ibuprofen 125 mg (NSAID nonsteroidal anti-inflammatory drug ) Pain reliever
Inactive Ingredients
Inactive ingredients carnauba wax colloidal silicon dioxide croscarmellose sodium ferric oxides glyceryl dibehenate hypromellose pharmaceutical ink polydextrose polyethylene glycol pregelatinized starch 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: Advil;II

Identifiers & Packaging

Container Type UNKNOWN
UNII
362O9ITL9D WK2XYI10QM
Packaging

PRINCIPAL DISPLAY PANEL Advil Dual Action

Package Descriptions
  • PRINCIPAL DISPLAY PANEL Advil Dual Action

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 during the last 3 months of 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.
Purpose

Active ingredients (in each caplet) Purposes Acetaminophen 250 mg Pain reliever Ibuprofen 125 mg (NSAID nonsteroidal anti-inflammatory drug ) 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.

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? call weekdays 9 AM to 5 PM at 1-800-88-ADVIL


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