612r-timely-ibuprofen Tablets 200 Mg

612r-timely-ibuprofen Tablets 200 Mg
SPL v2
SPL
SPL Set ID 82aad715-f652-471b-840c-5151c66e5ade
Route
ORAL
Published
Effective Date 2016-11-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Cellulose, Microcrystalline Croscarmellose Sodium Fd&c Yellow No. 6 Magnesium Stearate Polyethylene Glycol 3350 Polyvinyl Alcohol, Unspecified Silicon Dioxide Starch, Pregelatinized Corn Talc Titanium Dioxide Fd&c Yellow No. 6 Aluminum Lake Polyethylene Glycol, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: 115 Shape: capsule Shape: round Color: orange Size: 10 mm Size: 15 mm Score: 1
Marketing Status
ANDA Active Since 2016-11-16

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 pain due to:

-headache

-muscular aches

-minor pain of arthritis

-toothache

-backache

-the common cold

-menstrual cramps

  • temporarily reduces fever
Section 51945-4

Purposes

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 useand 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 every 4 to 6 hours while symptoms persist
    • if pain or fever does not respond to 1 caplet, 2 caplets may be used
    • do not exceed 6 caplets 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
  • read all warnings and directions before use
  • store at 20-25°C (68-77°F)
Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

Questions Or Comments?

Call 1-877-290-4008

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 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
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).

Active Ingredient (in Each Caplet)

Ibuprofen 200 mg (NSAID)*

* nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are
  • 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

  • temporarily relieves minor aches and pain due to:

-headache

-muscular aches

-minor pain of arthritis

-toothache

-backache

-the common cold

-menstrual cramps

  • temporarily reduces fever
Section 51945-4 (51945-4)

Purposes

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 useand 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 every 4 to 6 hours while symptoms persist
    • if pain or fever does not respond to 1 caplet, 2 caplets may be used
    • do not exceed 6 caplets 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 (Other information)
  • read all warnings and directions before use
  • store at 20-25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

Call 1-877-290-4008

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 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
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).

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Ibuprofen 200 mg (NSAID)*

* nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • 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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