SPL v1
SPL
SPL Set ID 70453c76-7f71-4edb-9c67-3741dc21d1d1
Route
ORAL
Published
Effective Date 2013-05-17
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Colloidal Silicon Dioxide Croscarmellose Sodium Magnesium Stearate Ferric Oxide Red Cellulose, Microcrystalline Polyethylene Glycols Talc Titanium Dioxide Starch, Corn Polyvinyl Alcohol

Identifiers & Packaging

Pill Appearance
Imprint: 117 Shape: capsule Color: brown Size: 15 mm Score: 1
Marketing Status
ANDA Active Since 2013-05-17
Description

Ibuprofen 200 mg (NSAID)* * nonstreoidal anti-inflammatory drug

Purpose

Pain reliever / fever reducer

Medication Information

Purpose

Pain reliever / fever reducer

Description

Ibuprofen 200 mg (NSAID)* * nonstreoidal anti-inflammatory drug

Use(s)
  • temporarily relieves minor aches and pain due to :
  • backache
  • headache
  • menstrual cramps
  • minor pain of arthritis
  • muscular aches
  • the common cold
  • toothache
  • temporarily reduces fever
Storage
  • Store between 20-250C(68-77 0F).
  • Do not use if seal under bottle cap imprinted with "SEALED  for YOUR PROTECTION" is broken or missing.
Warnings

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

Symptoms may include: 

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

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

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you:

  • are age 60 or older
  • have bad stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drug containing prescription NSAID (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • the more or for a longer time than directed
Directions
  • do not take more than directed
  • the smallest effective dose should be used
  • do not take longer than 10 days, unless directed by a doctor

    (see Warnings)

 

adults and children 12 years and older
  • take 1 tablet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 tablet, 2 tablets may be used
  • do not exceed 6 tablets 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
Active Ingredient(s)

Ibuprofen 200 mg (NSAID)*

* nonstreoidal anti-inflammatory drug

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinised starch, talc, titanium dioxide.

Pregnancy/breastfeeding

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 a problems in the unborn child or complications during delivery.

Principal Display Panel

Carton Label PDP



Ibuprofen 200mg CAPLET



PAIN RELIEVER/ FEVER REDUCER (NSAID)



































When Using This Product
  • take with food or milk if stomach upset occurs
  • long term continuous use may increase the risk of heart attack or stroke
Ask A Doctor Before Use If

you have

  • problems or serious side effects from taking pain relievers or fever reducers
  • stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
  • ulcers
  • bleeding problems
  • high blood pressure
  • heart or kidney disease
  • taken a diuretics
  • reached age 60 or older
Stop Use and Ask Doctor If
  • you feel faint, vomit blood, or have bloody or black stools.

        These are signs of stomach bleeding.

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • stomach pain or upset gets worse or lasts
  • redness or swelling is present in painful area
  • any new symptoms appear
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)

Ask A Doctor Or Pharmacist Before Use If

you are

  • taking any other drugs containg an NSAID (prescription or nonprescription)
  • taking a blood thining (anticoagulant) or steriod drug
  • under a doctor’s care for any serious condition
  • taking aspirin for heart attacks or stroke, because ibuprofen may decrease this benefit of aspirin
  • taking any other drug

Structured Label Content

Use(s) (USE(S))
  • temporarily relieves minor aches and pain due to :
  • backache
  • headache
  • menstrual cramps
  • minor pain of arthritis
  • muscular aches
  • the common cold
  • toothache
  • temporarily reduces fever
Purpose (PURPOSE)

Pain reliever / fever reducer

Storage (STORAGE)
  • Store between 20-250C(68-77 0F).
  • Do not use if seal under bottle cap imprinted with "SEALED  for YOUR PROTECTION" is broken or missing.
Warnings (WARNINGS)

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

Symptoms may include: 

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

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

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you:

  • are age 60 or older
  • have bad stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drug containing prescription NSAID (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • the more or for a longer time than directed
Directions (DIRECTIONS)
  • do not take more than directed
  • the smallest effective dose should be used
  • do not take longer than 10 days, unless directed by a doctor

    (see Warnings)

 

adults and children 12 years and older
  • take 1 tablet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 tablet, 2 tablets may be used
  • do not exceed 6 tablets 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
Active Ingredient(s) (ACTIVE INGREDIENT(S))

Ibuprofen 200 mg (NSAID)*

* nonstreoidal anti-inflammatory drug

Inactive Ingredients (INACTIVE INGREDIENTS)

colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinised starch, talc, titanium dioxide.

Pregnancy/breastfeeding (PREGNANCY/BREASTFEEDING)

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 a problems in the unborn child or complications during delivery.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Carton Label PDP



Ibuprofen 200mg CAPLET



PAIN RELIEVER/ FEVER REDUCER (NSAID)



































When Using This Product (WHEN USING THIS PRODUCT)
  • take with food or milk if stomach upset occurs
  • long term continuous use may increase the risk of heart attack or stroke
Ask A Doctor Before Use If (ASK A DOCTOR BEFORE USE IF)

you have

  • problems or serious side effects from taking pain relievers or fever reducers
  • stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
  • ulcers
  • bleeding problems
  • high blood pressure
  • heart or kidney disease
  • taken a diuretics
  • reached age 60 or older
Stop Use and Ask Doctor If (STOP USE AND ASK DOCTOR IF)
  • you feel faint, vomit blood, or have bloody or black stools.

        These are signs of stomach bleeding.

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • stomach pain or upset gets worse or lasts
  • redness or swelling is present in painful area
  • any new symptoms appear
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. (1-800-222-1222)

Ask A Doctor Or Pharmacist Before Use If (ASK A DOCTOR OR PHARMACIST BEFORE USE IF)

you are

  • taking any other drugs containg an NSAID (prescription or nonprescription)
  • taking a blood thining (anticoagulant) or steriod drug
  • under a doctor’s care for any serious condition
  • taking aspirin for heart attacks or stroke, because ibuprofen may decrease this benefit of aspirin
  • taking any other drug

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:37.828634 · Updated: 2026-03-14T22:53:29.712463