Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID 2f193146-74b2-4941-893d-3d2f5c8ee659
Route
ORAL
Published
Effective Date 2024-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: IB200 Shape: capsule Color: blue Size: 18 mm Score: 1
Marketing Status
ANDA Active Since 2018-03-31

Description

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)* (present as the free acid and potassium salt) *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/ fever reducer


Medication Information

Purpose

Pain reliever/ fever reducer

Description

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)* (present as the free acid and potassium salt) *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
    • muscular cramps
  • temporarily reduces fever
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
Product Label
H-E-B Ibuprofen Capsules 200 mg
Other Information
  • each capsule contains: potassium 20 mg
  • read all warnings and directions before use.
  • store at 20° to 25°C (68° to 77°F)
  • avoid excessive heat above 40°C (104°F). Protect from light.
  • swallow whole; do not crush, chew, or dissolve
Inactive Ingredients

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

Questions & Comments

Call toll free: 1-877-753-3935 Monday-Friday 9AM-5PM EST 

Principal Display Panel

Compare to Advil® Liquid-Gels® active ingredient**

Ibuprofen

Capsules, 200 mg

Pain Reliever/Fever Reducer (NSAID)

For Body Aches and Pain

CAPSULES

SOFTGELS

(Liquid Filled Capsules)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

**This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, distributor of Advil® Liqui-Gels®.

MADE WITH PRIDE AND CARE FOR H-E-B®, SAN ANTONIO, TX 78204

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



Ask A Doctor Before Use If
  • the 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 problem or stroke:
    • chest pain
    • slurred speech
    • trouble breathing
    • leg swelling
    • 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

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.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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

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
    • muscular cramps
  • temporarily reduces fever
Purpose

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
Product Label
H-E-B Ibuprofen Capsules 200 mg
Other Information (Other information)
  • each capsule contains: potassium 20 mg
  • read all warnings and directions before use.
  • store at 20° to 25°C (68° to 77°F)
  • avoid excessive heat above 40°C (104°F). Protect from light.
  • swallow whole; do not crush, chew, or dissolve
Inactive Ingredients (Inactive ingredients)

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

Questions & Comments

Call toll free: 1-877-753-3935 Monday-Friday 9AM-5PM EST 

Principal Display Panel

Compare to Advil® Liquid-Gels® active ingredient**

Ibuprofen

Capsules, 200 mg

Pain Reliever/Fever Reducer (NSAID)

For Body Aches and Pain

CAPSULES

SOFTGELS

(Liquid Filled Capsules)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

**This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, distributor of Advil® Liqui-Gels®.

MADE WITH PRIDE AND CARE FOR H-E-B®, SAN ANTONIO, TX 78204

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)
  • the 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 problem or stroke:
    • chest pain
    • slurred speech
    • trouble breathing
    • leg swelling
    • 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 (1-800-222-1222) right away.

Active Ingredient (in Each Capsule) (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

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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