70453c76-7f71-4edb-9c67-3741dc21d1d1

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
Purpose

Pain reliever / fever reducer

Description

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

Medication Information

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
Purpose

Pain reliever / fever reducer

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
Inactive Ingredients

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

Description

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

Principal Display Panel

Carton Label PDP



Ibuprofen 200mg CAPLET



PAIN RELIEVER/ FEVER REDUCER (NSAID)



































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.
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

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.

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

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
Purpose (PURPOSE)

Pain reliever / fever reducer

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
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.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Carton Label PDP



Ibuprofen 200mg CAPLET



PAIN RELIEVER/ FEVER REDUCER (NSAID)



































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
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.
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

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.

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