Ibuprofen Tablets, Usp (nsaid)pain Reliever/ Fever Reducer Drug Facts

Ibuprofen Tablets, Usp (nsaid)pain Reliever/ Fever Reducer Drug Facts
SPL v3
SPL
SPL Set ID a6e57acd-b02a-472e-9cc6-8d4aea246164
Route
ORAL
Published
Effective Date 2010-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Anhydrous Lactose Carnauba Wax Silicon Dioxide Hypromellose Magnesium Stearate Cellulose, Microcrystalline Povidone Sodium Lauryl Sulfate Starch, Corn Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: IP;142 Shape: oval Color: brown Size: 13 mm Score: 1
Marketing Status
ANDA Active Since 2009-09-16
Description

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

Purpose

Pain reliever/fever reducer USES temporarily relieves minor aches and pains due to: headache muscular aches minor pain or arthritis toothache backache the common cold menstrual cramps temporarily reduces fever

Medication Information

Purpose

Pain reliever/fever reducer

USES
  • temporarily relieves minor aches and pains due to:
  • headache
  • muscular aches
  • minor pain or arthritis
  • toothache
  • backache
  • the common cold
  • menstrual cramps
  • temporarily reduces fever
Description

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

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.

Alcohol Warning: If you consume 3 or more alcohol drinks per day, ask your Doctor whether you should take Ibuprofen or other pain relievers/fever reducers.

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 had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing NSAID (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
Ask Doctor

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 diuretic
  • reached age 60 or older

Ask a doctor before use if you are

  • taking aspirin for heart attack or stroke because ibuprofen may decrease this benefit of aspirin
  • taking any other drug containing an NSAID (prescription or nonprescription)
  • taking a blood thinning (anticoagulant) or steroid drug
  • under a doctor's care for any serious condition
  • taking any other drug
  • consuming 3 or more alcohol drinks per day

Directions
  • do not take longer than 10 days, unless directed by a doctor (see Warnings)




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 a 24-hour period, unless directed by a physician
  • take with food or milk, if occasional and mild heartburn, upset stomach, or stomach pain occurs with use
  • consult a physician if these symptoms are more thsn mild or if they persist
Children under 12 years
  • not for 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
(in each Tablet)

Ibuprofen 200 mg (NSAID)**

**nonsteroidal anti-inflammatory drug

Other Information
Other information
  • store at 15 – 30°C (59-86°F).
Inactive ingredients

Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Hypromellose, Iron Oxide Red, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Corn Starch, Titanium Dioxide.



Questions Or Comments
Call 1-800-262-5244

Monday though Friday 9AM – 2PM MST

Distributed by:

RejuviLife, Phoenix, AZ

RejuviLife is a trademark of Apotheca Inc.

When Using This Product
  • take with food or milk if stomach upset occurs
  • long term continuous use ay increase the risk of heart attack or stroke
Stop Use and Ask A 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 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 during the last 3 months of 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 1-800-362-0101 (Arizona only) immediately.

Package Label,principal Display Panel,additional Labels Upon Request

NDC 12634-860-01

IBUPROFEN

MAXIMUM STRENGTH

WITHOUT A PRESCRIPTION

Pain Reliever

Fever Reducer

RejuviLife®

100 CAPLETS

200 MG

Structured Label Content

Purpose (PURPOSE)

Pain reliever/fever reducer

USES
  • temporarily relieves minor aches and pains due to:
  • headache
  • muscular aches
  • minor pain or arthritis
  • toothache
  • backache
  • the common cold
  • menstrual cramps
  • temporarily reduces fever
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.

Alcohol Warning: If you consume 3 or more alcohol drinks per day, ask your Doctor whether you should take Ibuprofen or other pain relievers/fever reducers.

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 had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing NSAID (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
Ask Doctor (ASK DOCTOR)

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 diuretic
  • reached age 60 or older

Ask a doctor before use if you are

  • taking aspirin for heart attack or stroke because ibuprofen may decrease this benefit of aspirin
  • taking any other drug containing an NSAID (prescription or nonprescription)
  • taking a blood thinning (anticoagulant) or steroid drug
  • under a doctor's care for any serious condition
  • taking any other drug
  • consuming 3 or more alcohol drinks per day

Directions (DIRECTIONS)
  • do not take longer than 10 days, unless directed by a doctor (see Warnings)




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 a 24-hour period, unless directed by a physician
  • take with food or milk, if occasional and mild heartburn, upset stomach, or stomach pain occurs with use
  • consult a physician if these symptoms are more thsn mild or if they persist
Children under 12 years
  • not for use
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 (ACTIVE INGREDIENT)
(in each Tablet)

Ibuprofen 200 mg (NSAID)**

**nonsteroidal anti-inflammatory drug

Other Information (OTHER INFORMATION)
Other information
  • store at 15 – 30°C (59-86°F).
Inactive ingredients

Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Hypromellose, Iron Oxide Red, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Corn Starch, Titanium Dioxide.



Questions Or Comments (QUESTIONS OR COMMENTS)
Call 1-800-262-5244

Monday though Friday 9AM – 2PM MST

Distributed by:

RejuviLife, Phoenix, AZ

RejuviLife is a trademark of Apotheca Inc.

When Using This Product (WHEN USING THIS PRODUCT)
  • take with food or milk if stomach upset occurs
  • long term continuous use ay increase the risk of heart attack or stroke
Stop Use and Ask A Doctor If (STOP USE AND ASK A 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 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 during the last 3 months of 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 1-800-362-0101 (Arizona only) immediately.

Package Label,principal Display Panel,additional Labels Upon Request (PACKAGE LABEL,PRINCIPAL DISPLAY PANEL,ADDITIONAL LABELS UPON REQUEST)

NDC 12634-860-01

IBUPROFEN

MAXIMUM STRENGTH

WITHOUT A PRESCRIPTION

Pain Reliever

Fever Reducer

RejuviLife®

100 CAPLETS

200 MG

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:00.193617 · Updated: 2026-03-14T22:52:17.029964