3852, 3846, 3909

3852, 3846, 3909
SPL v13
SPL
SPL Set ID 237bcb87-64a0-415b-bd53-e9d3b8bf33b6
Route
ORAL
Published
Effective Date 2018-11-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Croscarmellose Sodium Starch, Corn Cellulose, Microcrystalline Stearic Acid Sodium Starch Glycolate Type A Corn Povidone K30 Silicon Dioxide Ferric Oxide Red Titanium Dioxide Polyethylene Glycol 400 Hydroxypropyl Cellulose, Unspecified Hypromelloses Polyvinyl Alcohol Fd&c Yellow No. 6 Talc Polysorbate 80 Carnauba Wax

Identifiers & Packaging

Pill Appearance
Imprint: C1 Shape: round Color: brown Color: orange Color: white Size: 6 mm Score: 1
Marketing Status
ANDA Active Since 2014-01-15

Description

Important: Read all product information before using. DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. Drug Facts

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Important: Read all product information before using. DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. Drug Facts

Uses

Temporarily relieves minor aches and pains due to:

  • headache
  • muscular ache
  • minor pain of arthritis
  • toothache
  • backache
  • the common cold
  • menstrual cramps
  • temporarily reduces fever
Section 42229-5

Important: Read all product information before using.

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Drug Facts

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 non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for longer time than directed

Heart attack and stroke warning: NSAIDs, except aspirin, increases 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 of age 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 of age: ■ 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
Inactive Ingredients

(White) Carnauba Wax, Croscarmellose Sodium, Hypromellose, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Povidone, Pregelatinized Starch, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid, and Titanium Dioxide.

(Orange) Croscarmellose Sodium, FD&C Yellow #6 Lake, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Pregelatinized Starch, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid, Talc and Titanium Dioxide.

(Brown) Croscarmellose Sodium, Hydroxypropylcellulose, Hypromellose, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Pregelatinized Starch, Red Iron Oxide, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid, and Titanium Dioxide.

Questions Or Comments?

Call 1-800-231-4670: weekdays 9:00 AM to 5:00 PM EST

When Using This Product
  • take with food or milk if stomach upset occurs
Ask 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 and 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 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 (1-800-222-1222) right away.

Active Ingredient (in Each Tablet)

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Package Label.principal Display Panel

See New Warnings



CONTRACT PHARMACAL CORP NDC 10267-3909-2



**Compares to the active ingredient in Motrin ®IB



GLUTEN FREE

Ibuprofen Tablets, USP 200 mg



Pain Reliever/Fever Reducer



(NSAID)



250 Coated Tablets



DYE-FREE



NOT ACTUAL SIZE

See New Warnings



CONTRACT PHARMACAL CORP NDC 10267-3846-2



**Compares to the active ingredient in Motrin ®IB



GLUTEN FREE

Ibuprofen Tablets, USP 200 mg



Pain Reliever/Fever Reducer



(NSAID)



250 Coated Tablets



NOT ACTUAL SIZE

See New Warnings



CONTRACT PHARMACAL CORP NDC 10267-3852-2



**Compares to the active ingredient in Motrin ®IB



GLUTEN FREE

Ibuprofen Tablets, USP 200 mg



Pain Reliever/Fever Reducer



(NSAID)



250 Coated Tablets



NOT ACTUAL SIZE

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 (USES)

Temporarily relieves minor aches and pains due to:

  • headache
  • muscular ache
  • minor pain of arthritis
  • toothache
  • backache
  • the common cold
  • menstrual cramps
  • temporarily reduces fever
Section 42229-5 (42229-5)

Important: Read all product information before using.

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Drug Facts

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 non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for longer time than directed

Heart attack and stroke warning: NSAIDs, except aspirin, increases 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 of age 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 of age: ■ 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
Inactive Ingredients (INACTIVE INGREDIENTS)

(White) Carnauba Wax, Croscarmellose Sodium, Hypromellose, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Povidone, Pregelatinized Starch, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid, and Titanium Dioxide.

(Orange) Croscarmellose Sodium, FD&C Yellow #6 Lake, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Pregelatinized Starch, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid, Talc and Titanium Dioxide.

(Brown) Croscarmellose Sodium, Hydroxypropylcellulose, Hypromellose, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Pregelatinized Starch, Red Iron Oxide, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid, and Titanium Dioxide.

Questions Or Comments? (QUESTIONS or COMMENTS?)

Call 1-800-231-4670: weekdays 9:00 AM to 5:00 PM EST

When Using This Product (WHEN USING this product)
  • take with food or milk if stomach upset occurs
Ask Doctor Before Use If (ASK 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 and 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 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 (1-800-222-1222) right away.

Active Ingredient (in Each Tablet) (ACTIVE INGREDIENT (in each tablet))

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

See New Warnings



CONTRACT PHARMACAL CORP NDC 10267-3909-2



**Compares to the active ingredient in Motrin ®IB



GLUTEN FREE

Ibuprofen Tablets, USP 200 mg



Pain Reliever/Fever Reducer



(NSAID)



250 Coated Tablets



DYE-FREE



NOT ACTUAL SIZE

See New Warnings



CONTRACT PHARMACAL CORP NDC 10267-3846-2



**Compares to the active ingredient in Motrin ®IB



GLUTEN FREE

Ibuprofen Tablets, USP 200 mg



Pain Reliever/Fever Reducer



(NSAID)



250 Coated Tablets



NOT ACTUAL SIZE

See New Warnings



CONTRACT PHARMACAL CORP NDC 10267-3852-2



**Compares to the active ingredient in Motrin ®IB



GLUTEN FREE

Ibuprofen Tablets, USP 200 mg



Pain Reliever/Fever Reducer



(NSAID)



250 Coated Tablets



NOT ACTUAL SIZE

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

All Sections (JSON)