Dolex Flex (deactivated)

Dolex Flex (deactivated)
SPL v3
SPL
SPL Set ID 822d9def-504c-9beb-e053-2991aa0a280e
Route
ORAL
Published
Effective Date 2019-02-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Sorbitan Fd&c Blue No. 1 Water Food Yellow 3 Free Acid Sorbitol Medium-chain Triglycerides Potassium Hydroxide Polyethylene Glycol, Unspecified Lecithin, Soybean Gelatin

Identifiers & Packaging

Pill Appearance
Imprint: AT146 Shape: oval Color: green Size: 19 mm
Marketing Status
ANDA Completed Since 2019-10-31 Until 2024-04-30

Description

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


Medication Information

Description

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

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
Section 55105-1
Active ingredient (in each capsule) Purpose
Solubilized ibuprofen equal to

200 mg ibuprofen (NSAID)*...............
Pain reliever/fever reducer

* nonsteroidal anti-inflammatory drug

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
Do Not Use
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
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.

Other Information
  • each capsule contains: potassium 20 mg
  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)
  • read all warnings and directions before use
  • retain carton for complete product information and warnings
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.

Questions Or Comments?

1-866-359-3478

(M-F) 9 AM - 5 PM EST or www.pharmadel.com

When Using This Product
  • take with food or milk if stomach upset occurs
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
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

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.

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)

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.

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


Structured Label Content

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
Section 55105-1 (55105-1)
Active ingredient (in each capsule) Purpose
Solubilized ibuprofen equal to

200 mg ibuprofen (NSAID)*...............
Pain reliever/fever reducer

* nonsteroidal anti-inflammatory drug

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
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
Allergy Alert: (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.

Other Information (Other information)
  • each capsule contains: potassium 20 mg
  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)
  • read all warnings and directions before use
  • retain carton for complete product information and warnings
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.

Questions Or Comments? (Questions or comments?)

1-866-359-3478

(M-F) 9 AM - 5 PM EST or www.pharmadel.com

When Using This Product (When using this product)
  • take with food or milk if stomach upset occurs
Stomach Bleeding Warning: (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
Ask A Doctor Before Use If (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

If Pregnant Or Breast Feeding, (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. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

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)

Heart Attack and Stroke Warning: (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.

Ask A Doctor Or Pharmacist Before Use If You Are (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


Advanced Ingredient Data


Raw Label Data

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