Dolex Flex IBUPROFEN PHARMADEL LLC FDA Approved Uses Temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps temporarily reduces fever
Generic: IBUPROFEN
Mfr: PHARMADEL LLC FDA #25 OTC
FunFoxMeds box
Substance Ibuprofen
Route
ORAL
Applications
ANDA206999
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredient Active ingredient (in each capsule) Purpose Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*............... Pain reliever/fever reducer * nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive ingredients FD&C blue no. 1 FD&C yellow no.6 gelatin lecithin (soybean) medium-chain triglycerides pharmaceutical ink polyethylene glycol potassium hydroxide purified water sorbitol sobitan.
Strengths
200 mg
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Due To Headache Muscular Aches Minor Pain Of Arthritis Toothache Backache The Common Cold Menstrual Cramps Temporarily Reduces Fever
Pill Appearance
Shape: oval Color: green Imprint: AT146

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
WK2XYI10QM
Packaging

Package Principal Display Panel DOLEX® FLEX Relief of MUSCULAR ACHES Solubilized Ibuprofen Capsules, 200 mg Pain Reliever / Fever Reducer (NSAID) 20 SOFTGELS** (**Liquid Filled Capsules) DF

Package Descriptions
  • Package Principal Display Panel DOLEX® FLEX Relief of MUSCULAR ACHES Solubilized Ibuprofen Capsules, 200 mg Pain Reliever / Fever Reducer (NSAID) 20 SOFTGELS** (**Liquid Filled Capsules) DF

Overview

Uses Temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps temporarily reduces fever

Indications & Usage

Uses Temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps temporarily reduces fever

Dosage & Administration

Directions do not take more than directed the smallest effective dose should be used adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 capsule, 2 capsules may be used do not exceed 6 capsules in 24 hours, unless directed by a doctor children under 12 years: ask a doctor

Warnings & Precautions
Warnings Allergy alert: Ibuprofen may cause a severeallergic 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 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 if you have ever had an allergic reaction to any other pain reliever/fever reducer 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 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 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 (1-800-222-1222). Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Allergy alert: Ibuprofen may cause a severeallergic 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 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.
Purpose

Active ingredient (in each capsule) Purpose Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*............... Pain reliever/fever reducer * nonsteroidal anti-inflammatory drug

Do Not Use

Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery

When Using

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

Questions

Questions or comments? 1-866-359-3478 (M-F) 9 AM - 5 PM EST or www.pharmadel.com


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