Ibuprofen Tablets, Usp 200 Mg

Ibuprofen Tablets, Usp 200 Mg
SPL v6
SPL
SPL Set ID 97516b9f-219a-429d-850d-1fe9fd66646b
Route
ORAL
Published
Effective Date 2021-12-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Silicon Dioxide Fd&c Yellow No. 6 Starch, Corn Povidone K30 Polyethylene Glycol, Unspecified Polyvinyl Alcohol Sodium Starch Glycolate Type A Potato Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: G2 Shape: oval Shape: round Color: orange Size: 14 mm Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2019-11-14

Description

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

Purpose

Pain reliever/ fever reducer


Medication Information

Purpose

Pain reliever/ fever reducer

Description

Ibuprofen 200 mg (NSAID) * * 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



■ menstrual 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 older

  • take 1 caplet/tablet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 caplet/tablet, 2 caplets/tablets may be used
  • do not exceed 6 caplets/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 ibuprofen or any other pain reliever/fever reducer

■ right before or after heart surgery

Other Information

• store between 20° – 25°C (68 – 77°F).

• do not use if neck wrap or foil inner seal is broken or missing

Active Ingredient(s)

Ibuprofen 200 mg (NSAID) *

*nonsteroidal anti-inflammatory drug

Inactive Ingredients

colloidal silicon dioxide, FD&C Yellow #6, maize starch, Povidone k30, polyethylene glycol, polyvinyl alcohol,  pregelatinized starch, sodium starch glycolate, stearic acid, talc titanium dioxide

Questions Or Comments

Call 1-877-770-3183

weekdays 9:00 AM to 4:30 PM EST

Principal Display Panel

When Using This Product

■ take with food or milk if stomach upset occurs

Ask A Doctor Before Use If

■ you have problems or serious side effects from taking pain relievers or fever reducers

■ the stomach bleeding warning applies to you

■ 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 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

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 right away. (1-800-222-1222)

Ask A Doctor Or Pharmacist Before Use If

■ taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin

■ under a doctor's care for any serious condition

■ taking any other drug


Structured Label Content

Uses (USES)

■ temporarily relieves minor aches and pains due to:



■ headache



■ muscular aches



■ minor pain of arthritis



■ toothache



■ backache



■ the common cold



■ menstrual cramps



■ temporarily reduces fever

Purpose (PURPOSE)

Pain reliever/ fever reducer

Warnings (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 (DIRECTIONS)

• do not take more than directed

• the smallest effective dose should be used

  adults and children 12 years and older

  • take 1 caplet/tablet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 caplet/tablet, 2 caplets/tablets may be used
  • do not exceed 6 caplets/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 ibuprofen or any other pain reliever/fever reducer

■ right before or after heart surgery

Other Information

• store between 20° – 25°C (68 – 77°F).

• do not use if neck wrap or foil inner seal is broken or missing

Active Ingredient(s) (ACTIVE INGREDIENT(S))

Ibuprofen 200 mg (NSAID) *

*nonsteroidal anti-inflammatory drug

Inactive Ingredients

colloidal silicon dioxide, FD&C Yellow #6, maize starch, Povidone k30, polyethylene glycol, polyvinyl alcohol,  pregelatinized starch, sodium starch glycolate, stearic acid, talc titanium dioxide

Questions Or Comments (QUESTIONS OR COMMENTS)

Call 1-877-770-3183

weekdays 9:00 AM to 4:30 PM EST

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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)

■ you have problems or serious side effects from taking pain relievers or fever reducers

■ the stomach bleeding warning applies to you

■ 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 Doctor If (STOP USE AND ASK 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

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 right away. (1-800-222-1222)

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

■ taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin

■ under a doctor's care for any serious condition

■ taking any other drug


Advanced Ingredient Data


Raw Label Data

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