Rapidcare - Ibuprofen Tablets, Usp 200mg

Rapidcare - Ibuprofen Tablets, Usp 200mg
SPL v1
SPL
SPL Set ID dcb559e6-f8b8-a4a5-e053-2995a90ab187
Route
ORAL
Published
Effective Date 2022-04-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Silicon Dioxide Polydextrose Polyethylene Glycol, Unspecified Povidone Titanium Dioxide Sodium Starch Glycolate Type A Potato Fd&c Yellow No. 6 Hypromellose, Unspecified Water Stearic Acid Starch, Corn

Identifiers & Packaging

Pill Appearance
Shape: round Color: red Size: 10 mm
Marketing Status
ANDA Active Since 2022-04-15

Description

Ibuprofen USP, 200mg (NSAID)* *nonsteroidal anti-inflammatory drug


Medication Information

Warnings and Precautions

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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chances are 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.

Description

Ibuprofen USP, 200mg (NSAID)* *nonsteroidal anti-inflammatory drug

Uses

temporarily relieves minor aches and pains due to:

  • headache
  • toothache
  • backache
  • menstrual cramps
  • the common cold
  • muscular aches
  • minor pain of arthritis
  • temporarily reduces fever
Section 50565-1

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. right away.

Section 50566-9

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
Section 50567-7

When using this product take with food or milk if stomach upset occurs

Section 50568-5

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
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 have high blood pressure, heart
  • disease, liver cirrhosis, kidney disease, asthma, or stroke
  • you are taking a diuretic
Section 50570-1
  • right before or after heart surgery
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer

Section 51727-6

colloidal silicon dioxide, corn starch, FD&C yellow #6, hypromellose, polydextrose, polyethylene glycol, povidone,

pregelatinized starch, purified water, sodium starch glycolate, stearic acid, titanium dioxide

Section 51945-4

Section 53414-9

If pregnant or breast-feeding, 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

Section 55105-1

Pain reliever/fever reducer

Directions
  • do not take more than directed
  • the smallest effective dose should be used

adults and children 12 years and over:

  • 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
Other Information
  • Tamper Evident. Do not use if packet is torn or opened
  • Store at controlled room temperature 20° to 25°C (68° to 77°F)
  • Avoid excessive heat and humidity
Active Ingredient (in Each Tablet)

Ibuprofen USP, 200mg (NSAID)*

*nonsteroidal anti-inflammatory drug


Structured Label Content

Uses (USES)

temporarily relieves minor aches and pains due to:

  • headache
  • toothache
  • backache
  • menstrual cramps
  • the common cold
  • muscular aches
  • minor pain of arthritis
  • temporarily reduces fever
Warnings and Precautions (34071-1)

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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chances are 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.

Section 50565-1 (50565-1)

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. right away.

Section 50566-9 (50566-9)

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
Section 50567-7 (50567-7)

When using this product take with food or milk if stomach upset occurs

Section 50568-5 (50568-5)

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
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 have high blood pressure, heart
  • disease, liver cirrhosis, kidney disease, asthma, or stroke
  • you are taking a diuretic
Section 50570-1 (50570-1)
  • right before or after heart surgery
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer

Section 51727-6 (51727-6)

colloidal silicon dioxide, corn starch, FD&C yellow #6, hypromellose, polydextrose, polyethylene glycol, povidone,

pregelatinized starch, purified water, sodium starch glycolate, stearic acid, titanium dioxide

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, 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

Section 55105-1 (55105-1)

Pain reliever/fever reducer

Directions
  • do not take more than directed
  • the smallest effective dose should be used

adults and children 12 years and over:

  • 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
Other Information (Other information)
  • Tamper Evident. Do not use if packet is torn or opened
  • Store at controlled room temperature 20° to 25°C (68° to 77°F)
  • Avoid excessive heat and humidity
Active Ingredient (in Each Tablet) (Active Ingredient (in each tablet))

Ibuprofen USP, 200mg (NSAID)*

*nonsteroidal anti-inflammatory drug


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)