Ibuprofen, Solubilized, 24/7 Life By 7-eleven Tm

Ibuprofen, Solubilized, 24/7 Life By 7-eleven Tm
SPL v1
SPL
SPL Set ID 45253158-026f-eae3-e063-6294a90a6707
Route
ORAL
Published
Effective Date 2022-04-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Gelatin, Unspecified Polyethylene Glycol, Unspecified Sorbitan Potassium Hydroxide Water Fd&c Blue No. 1 Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: IB1 Shape: oval Color: blue Size: 20 mm Score: 1
Marketing Status
ANDA Active Since 2022-04-19

Description

Drug Facts

Purpose

Purpose Pain reliever/fever reducer


Medication Information

Purpose

Purpose

Pain reliever/fever reducer

Description

Drug Facts

Uses

Uses

  • temporarily relieves minor aches and pains due to:
  • minor pain of arthritis
  • headache
  • the common cold
  • backache
  • menstrual cramps
  • toothache
  • muscular aches
  • temporarily reduces fever
Section 50569-3

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 are taking a diuretic
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
Warnings

Warnings

Directions

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
Drug Facts

Drug Facts

Allergy Alert

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.

Symptoms may include:

  • facial swelling
  • blisters
  • shock
  • hives
  • skin reddening
  • asthma (wheezing)
  • rash

If an allergic reaction occurs, stop use and seek medical help right away.

Active Ingredient

Active ingredient (in each capsule)

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*

(present as the free acid and potassium salt)

*nonsteroidal anti-inflammatory drug

Other Information

Other information

  • each capsule contains: potassium 20 mg
  • store at 20° to 25°C (68° to 77°F)
  • avoid excessive heat above 40°C (104°F). Protect from light.
Inactive Ingredients

Inactive ingredients

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

Questions Or Comments

Questions or comments?

1-877-507-6516 (M-F, 8AM – 4:30PM CST)

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

  • have had stomach ulcers or bleeding problems
  • take more or for a longer time than directed
  • take a blood thinning (anticoagulant) or steroid drug
  • have 3 or more alcoholic drinks every day while using this product
  • are age 60 or older
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
Stop Use and Ask A Doctor If

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
  • vomit blood
  • have bloody or black stools
  • feel faint
  • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke:
  • chest pain
  • trouble breathing
  • leg swelling
  • slurred speech
  • weakness in one part or side of body
  • 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 at 20 weeks or later in 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.

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

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
Ibuprofin, Solubilized Capsules, 24/7 Life By 7 Eleven Tm

[ 24/7 Life by 7-Eleven TM logo]

Ibuprofen

Solubilized Ibuprofen Capsules,


200 mg

Pain Reliever/Fever Reducer (NSAID)

compare to ADVIL ® LIQUI-GELS ®

active ingredient**

20

LIQUID-FILLED

CAPSULES

Actual Size

[liquid-filled capsule image]


Structured Label Content

Uses

Uses

  • temporarily relieves minor aches and pains due to:
  • minor pain of arthritis
  • headache
  • the common cold
  • backache
  • menstrual cramps
  • toothache
  • muscular aches
  • temporarily reduces fever
Section 50569-3 (50569-3)

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 are taking a diuretic
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
Purpose

Purpose

Pain reliever/fever reducer

Warnings

Warnings

Directions

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)

Do not use

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
Drug Facts

Drug Facts

Allergy Alert (Allergy alert)

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.

Symptoms may include:

  • facial swelling
  • blisters
  • shock
  • hives
  • skin reddening
  • asthma (wheezing)
  • rash

If an allergic reaction occurs, stop use and seek medical help right away.

Active Ingredient (Active ingredient)

Active ingredient (in each capsule)

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*

(present as the free acid and potassium salt)

*nonsteroidal anti-inflammatory drug

Other Information (Other information)

Other information

  • each capsule contains: potassium 20 mg
  • store at 20° to 25°C (68° to 77°F)
  • avoid excessive heat above 40°C (104°F). Protect from light.
Inactive Ingredients (Inactive ingredients)

Inactive ingredients

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

Questions Or Comments (Questions or comments)

Questions or comments?

1-877-507-6516 (M-F, 8AM – 4:30PM CST)

When Using This Product (When using this product)

When using this product

  • take with food or milk if stomach upset occurs
Stomach Bleeding Warning (Stomach bleeding warning)

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

  • have had stomach ulcers or bleeding problems
  • take more or for a longer time than directed
  • take a blood thinning (anticoagulant) or steroid drug
  • have 3 or more alcoholic drinks every day while using this product
  • are age 60 or older
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
  • vomit blood
  • have bloody or black stools
  • feel faint
  • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke:
  • chest pain
  • trouble breathing
  • leg swelling
  • slurred speech
  • weakness in one part or side of body
  • 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)

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in 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)

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

Heart Attack and Stroke Warning (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 (Ask a doctor or pharmacist before use if)

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
Ibuprofin, Solubilized Capsules, 24/7 Life By 7 Eleven Tm (Ibuprofin, Solubilized Capsules, 24/7 Life by 7-Eleven TM)

[ 24/7 Life by 7-Eleven TM logo]

Ibuprofen

Solubilized Ibuprofen Capsules,


200 mg

Pain Reliever/Fever Reducer (NSAID)

compare to ADVIL ® LIQUI-GELS ®

active ingredient**

20

LIQUID-FILLED

CAPSULES

Actual Size

[liquid-filled capsule image]


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)