Dolex Flex (hhh)

Dolex Flex (hhh)
SPL v4
SPL
SPL Set ID 0543420d-a250-065d-e063-6294a90a005e
Route
ORAL
Published
Effective Date 2023-09-07
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 Sorbitol Potassium Hydroxide Polyethylene Glycol, Unspecified Gelatin

Identifiers & Packaging

Pill Appearance
Imprint: IB1 Shape: oval Color: blue Size: 20 mm
Marketing Status
ANDA Active Since 2023-09-01

Description

Active ingredient (in each capsule) Purposes Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID*). ............................ (present as the free acid and potassium salt) * nonsteroidal anti-inflammatory drug Pain reliever/ fever reducer


Medication Information

Description

Active ingredient (in each capsule) Purposes Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID*). ............................ (present as the free acid and potassium salt) * nonsteroidal anti-inflammatory drug Pain reliever/ fever reducer

Uses
  • temporarily relieves minor aches and pains due to:
  • headache
  • toothache
  • backache
  • menstrual cramps
  • the common cold
  • muscular aches
  • minor pain from arthritis
  • and to reduce fever
Section 55105-1
Active ingredient (in each capsule) Purposes
Solubilized ibuprofen equal to

200 mg ibuprofen (NSAID*).............................

(present as the free acid and potassium salt)

* nonsteroidal anti-inflammatory drug

Pain reliever/ fever reducer

Warnings

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 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.

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
Other Information
  • each capsule contains: 20mg potassium
  • store at 68-77°F (20-25°C)
  • avoid excessive heat above 104°F (40°C)
Inactive Ingredients

FD&C blue #1, gelatin, polyethylene glycol, potassium hydroxide, purified water, sorbitol and sorbitan

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
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
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
  • slurred speech
  • weakness in one part or side of body
  • 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
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.

Package Principal Display Panel

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
  • toothache
  • backache
  • menstrual cramps
  • the common cold
  • muscular aches
  • minor pain from arthritis
  • and to reduce fever
Section 55105-1 (55105-1)
Active ingredient (in each capsule) Purposes
Solubilized ibuprofen equal to

200 mg ibuprofen (NSAID*).............................

(present as the free acid and potassium salt)

* nonsteroidal anti-inflammatory drug

Pain reliever/ fever reducer

Warnings

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 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.

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
Other Information (Other information)
  • each capsule contains: 20mg potassium
  • store at 68-77°F (20-25°C)
  • avoid excessive heat above 104°F (40°C)
Inactive Ingredients (Inactive ingredients)

FD&C blue #1, gelatin, polyethylene glycol, potassium hydroxide, purified water, sorbitol and sorbitan

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
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
Stop Use and Ask A Doctor If (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
  • slurred speech
  • weakness in one part or side of body
  • 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
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. (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

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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