CAREALL Ibuprofen IBUPROFEN NEW WORLD IMPORTS FDA Approved Temporarily relieves minor aches and pains due to: Headache, toothache, backache, menstrual cramps, the common cold, muscular aches, minor pain of arthritis. Temporarily reduces fever
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Substance Ibuprofen
Route
ORAL
Applications
ANDA079174
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Ibuprofen 200mg (NSAID)** **nonsteroidal anti-inflammatory drug
Inactive Ingredients
colloidal silicon dioxide corn starch FD and C yellow 6 hypromellose polydextrose polyethylene glycol povidone pregelatinized starch purified water sodium starch glycolate stearic acid titanium dioxide
Strengths
200 mg
Treats Conditions
Temporarily Relieves Minor Aches And Pains Due To Headache Toothache Backache Menstrual Cramps The Common Cold Muscular Aches Minor Pain Of Arthritis Temporarily Reduces Fever
Pill Appearance
Shape: round Color: brown Imprint: G2

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0085317005023
UNII
WK2XYI10QM
Packaging

IBUT100 Label

Package Descriptions
  • IBUT100 Label

Overview

Temporarily relieves minor aches and pains due to: Headache, toothache, backache, menstrual cramps, the common cold, muscular aches, minor pain of arthritis. Temporarily reduces fever

Indications & Usage

Temporarily relieves minor aches and pains due to: Headache, toothache, backache, menstrual cramps, the common cold, muscular aches, minor pain of arthritis. Temporarily reduces fever

Dosage & Administration

Do not take more than directed. The smallest effective dose should be used. Adult and children 12 years and older: Take 1 tablets every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablets, 2 tablets may be used. Do not exceed 6 tablets in 24 hours unless directed by a doctor. Children under 12 years: ask a doctor

Warnings & Precautions
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. Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you are 60 years or older, have had stomach ulcers or bleeding problems, take a blood thinning (anticoaglant) or steroid drug, take other drugs containing a NSAID [aspirin, ibuprofen, naproxen, or others], have 3 or more alcoholic drinks every day while using this product, or take more / for a longer time than directed. ​Heart attack and stroke warning: ​NSAID's, 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 if you have ever had an allergic reaction to any other pain reliever / fever reducer or right before or after heart surgery. Ask a doctor before use if: stomach bleeding warning applies to you. you have problems or serious side effects from taking pain relievers or fever reducers. 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: taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin. Under a doctor's care for any serious condition. 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, or leg swelling. Pain gets worse or lasts more than 10 days. Fever gets worse or lasts more than 3 days. Redness or swelling is present in the painful area. Any new symptoms appear. 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.
Purpose

Pain reliever / fever reducer

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)

Questions

Questions or Comments: Call 1-888-952-0050 Monday through Friday 9 AM - 5 PM EST


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