SPL v11
SPL
SPL Set ID 403ec259-3be1-4e0b-ab7b-fee213b7eabe
Route
ORAL
Published
Effective Date 2023-04-03
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Ammonia Fd&c Green No. 3 Gelatin, Unspecified Sorbitol Water Shellac Sorbitan Monooleate Polyethylene Glycol, Unspecified Propylene Glycol Potassium Hydroxide Ferrous Oxide Medium-chain Triglycerides

Identifiers & Packaging

Pill Appearance
Imprint: 62 Shape: capsule Color: green Size: 19 mm Size: 6 mm Score: 1
Marketing Status
ANDA Active Since 2020-08-18

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:

o headache

o toothache

o backache

o menstrual cramps

o the common cold

o muscular aches

o minor pain of arthritis

• 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 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: potassium 20 mg

• read all warnings and directions before use. Keep carton.

• store at 20-25ºC (68-77ºF)

• avoid excessive heat above 40°C (104°F).

Inactive Ingredients

ammonium hydroxide, FD&C Green No. 3, gelatin, iron oxide black, medium-chain triglycerides, polyethylene glycol, potassium hydroxide, propylene glycol, purified water, shellac, sorbitan monooleate, sorbitol sorbitan



Questions Or Comments?

call toll free 1-877-376-4271

Principal Display Panel

  Ibuprofen capsules 200 mg (Liquid Filled Capsules)



NDC 25000-133-43

Ibuprofen capsules 200 mg (Liquid filled capsules)

10's count bottle label







NDC 25000-133-43

Ibuprofen capsules 200 mg (Liquid filled capsules)

10's count carton label







NDC 25000-133-01

Ibuprofen capsules 200 mg (Liquid filled capsules)

20's count bottle label







NDC 25000-133-01

Ibuprofen capsules 200 mg (Liquid filled capsules)

20's count carton label







NDC 25000-133-04

Ibuprofen capsules 200 mg (Liquid filled capsules)

32's count bottle label







NDC 25000-133-04

Ibuprofen capsules 200 mg (Liquid filled capsules)

32's count carton label







NDC 25000-133-69

Ibuprofen capsules 200 mg (Liquid filled capsules)

300's count bottle label







NDC 25000-133-13

Ibuprofen capsules 200 mg (Liquid filled capsules)

600's count bottle label







Ibuprofen capsules 200 mg (Mini liquid filled capsules)

 

NDC 25000-062-43

Ibuprofen capsules 200 mg (Mini liquid filled capsules)

10's count bottle label







NDC 25000-062-43

Ibuprofen capsules 200 mg (Mini liquid filled capsules)

10's count carton label





 

NDC 25000-062-01

Ibuprofen capsules 200 mg (Mini liquid filled capsules)

20's count bottle label







NDC 25000-062-01

Ibuprofen capsules 200 mg (Mini liquid filled capsules)

20's count carton label







NDC 25000-062-04

Ibuprofen capsules 200 mg (Mini liquid filled capsules)

32's count bottle label







NDC 25000-062-04

Ibuprofen capsules 200 mg (Mini liquid filled capsules)

32's count carton label







NDC 25000-062-67

Ibuprofen capsules 200 mg (Mini liquid filled capsules)

80's count bottle label







NDC 25000-062-67

Ibuprofen capsules 200 mg (Mini liquid filled capsules)

80's count carton label







NDC 25000-062-69

Ibuprofen capsules 200 mg (Mini liquid filled capsules)

300's count PET bottle label







NDC 25000-062-13

Ibuprofen capsules 200 mg (Mini liquid filled capsules)

600's count bottle label











 





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
  • weakness in one part or side of body
  • slurred speech
  • 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
Keep Out of Reach of Children

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

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.

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:

o headache

o toothache

o backache

o menstrual cramps

o the common cold

o muscular aches

o minor pain of arthritis

• 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 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: potassium 20 mg

• read all warnings and directions before use. Keep carton.

• store at 20-25ºC (68-77ºF)

• avoid excessive heat above 40°C (104°F).

Inactive Ingredients (Inactive ingredients)

ammonium hydroxide, FD&C Green No. 3, gelatin, iron oxide black, medium-chain triglycerides, polyethylene glycol, potassium hydroxide, propylene glycol, purified water, shellac, sorbitan monooleate, sorbitol sorbitan



Questions Or Comments? (Questions or comments?)

call toll free 1-877-376-4271

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

  Ibuprofen capsules 200 mg (Liquid Filled Capsules)



NDC 25000-133-43

Ibuprofen capsules 200 mg (Liquid filled capsules)

10's count bottle label







NDC 25000-133-43

Ibuprofen capsules 200 mg (Liquid filled capsules)

10's count carton label







NDC 25000-133-01

Ibuprofen capsules 200 mg (Liquid filled capsules)

20's count bottle label







NDC 25000-133-01

Ibuprofen capsules 200 mg (Liquid filled capsules)

20's count carton label







NDC 25000-133-04

Ibuprofen capsules 200 mg (Liquid filled capsules)

32's count bottle label







NDC 25000-133-04

Ibuprofen capsules 200 mg (Liquid filled capsules)

32's count carton label







NDC 25000-133-69

Ibuprofen capsules 200 mg (Liquid filled capsules)

300's count bottle label







NDC 25000-133-13

Ibuprofen capsules 200 mg (Liquid filled capsules)

600's count bottle label







Ibuprofen capsules 200 mg (Mini liquid filled capsules)

 

NDC 25000-062-43

Ibuprofen capsules 200 mg (Mini liquid filled capsules)

10's count bottle label







NDC 25000-062-43

Ibuprofen capsules 200 mg (Mini liquid filled capsules)

10's count carton label





 

NDC 25000-062-01

Ibuprofen capsules 200 mg (Mini liquid filled capsules)

20's count bottle label







NDC 25000-062-01

Ibuprofen capsules 200 mg (Mini liquid filled capsules)

20's count carton label







NDC 25000-062-04

Ibuprofen capsules 200 mg (Mini liquid filled capsules)

32's count bottle label







NDC 25000-062-04

Ibuprofen capsules 200 mg (Mini liquid filled capsules)

32's count carton label







NDC 25000-062-67

Ibuprofen capsules 200 mg (Mini liquid filled capsules)

80's count bottle label







NDC 25000-062-67

Ibuprofen capsules 200 mg (Mini liquid filled capsules)

80's count carton label







NDC 25000-062-69

Ibuprofen capsules 200 mg (Mini liquid filled capsules)

300's count PET bottle label







NDC 25000-062-13

Ibuprofen capsules 200 mg (Mini liquid filled capsules)

600's count bottle label











 





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

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.

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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