Quality Choice 44-292 Delisted

Quality Choice 44-292 Delisted
SPL v17
SPL
SPL Set ID 6521bc47-4d9c-4a5b-b109-3841f3be4b6c
Route
ORAL
Published
Effective Date 2025-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Carnauba Wax Silicon Dioxide Starch, Corn Hypromellose, Unspecified Anhydrous Lactose Magnesium Stearate Microcrystalline Cellulose Polydextrose Polyethylene Glycol, Unspecified Ferric Oxide Red Sodium Starch Glycolate Type A Potato Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;292 Shape: oval Color: brown Size: 14 mm Score: 1
Marketing Status
ANDA Completed Since 1988-05-24 Until 2028-02-28

Description

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

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

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

Uses
  • temporarily relieves minor aches and pains due to:
    • backache
    • muscular aches

    • toothache
    • menstrual cramps

    • headache
    • the common cold

    • minor pain of arthritis

  • temporarily reduces fever

Warnings

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  • shock
  • facial swelling
  • blisters
  • rash

  • hives
  • skin reddening
  • asthma (wheezing)

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

  • take more or for a longer time than directed

  • take a blood thinning (anticoagulant) or steroid drug

  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • are age 60 or older

  • have had stomach ulcers or bleeding problems

  • have 3 or more alcoholic drinks every day while using this product

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 over: 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 any other pain reliever/fever reducer

  • right before or after heart surgery

Other Information
  • store between 20°-25°C (68°-77°F)

  • avoid excessive heat 40°C (104°F)

  • see end flap for expiration date and lot number

Inactive Ingredients

carnauba wax, colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide

Questions Or Comments?

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal Display Panel

QC®

QUALITY

CHOICE

NDC 63868-979-10

†Compare to the

Active Ingredient in

Advil® Caplets

Ibuprofen

Ibuprofen Tablets USP, 200 mg

Pain Reliever,

Fever Reducer (NSAID)

100 Coated Caplets

actual size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

†This product is not manufactured or distributed by

PF Consumer Healthcare 1 LLC, owner of the

registered trademark Advil® Caplets.

50844 REV1221C29212

Distributed by CDMA, Inc.

43157 W Nine Mile

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

SATISFACTION

GUARANTEED

100%

QC

QC 44-292

When Using This Product
  • take with food or milk if stomach upset occurs

Ask A Doctor Before Use If
  • stomach bleeding warning applies to you

  • you have a history of stomach problems, such as heartburn
  • you are taking a diuretic

  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke

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

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
    • slurred speech

    • leg swelling
    • trouble breathing

    • weakness in one part or side of body

  • 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.

Active Ingredient (in Each Brown Caplet)

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug



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


Structured Label Content

Uses
  • temporarily relieves minor aches and pains due to:
    • backache
    • muscular aches

    • toothache
    • menstrual cramps

    • headache
    • the common cold

    • minor pain of arthritis

  • temporarily reduces fever

Purpose

Pain reliever/fever reducer

Warnings

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  • shock
  • facial swelling
  • blisters
  • rash

  • hives
  • skin reddening
  • asthma (wheezing)

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

  • take more or for a longer time than directed

  • take a blood thinning (anticoagulant) or steroid drug

  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • are age 60 or older

  • have had stomach ulcers or bleeding problems

  • have 3 or more alcoholic drinks every day while using this product

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 over: 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 any other pain reliever/fever reducer

  • right before or after heart surgery

Other Information (Other information)
  • store between 20°-25°C (68°-77°F)

  • avoid excessive heat 40°C (104°F)

  • see end flap for expiration date and lot number

Inactive Ingredients (Inactive ingredients)

carnauba wax, colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide

Questions Or Comments? (Questions or comments?)

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal Display Panel (Principal display panel)

QC®

QUALITY

CHOICE

NDC 63868-979-10

†Compare to the

Active Ingredient in

Advil® Caplets

Ibuprofen

Ibuprofen Tablets USP, 200 mg

Pain Reliever,

Fever Reducer (NSAID)

100 Coated Caplets

actual size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

†This product is not manufactured or distributed by

PF Consumer Healthcare 1 LLC, owner of the

registered trademark Advil® Caplets.

50844 REV1221C29212

Distributed by CDMA, Inc.

43157 W Nine Mile

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

SATISFACTION

GUARANTEED

100%

QC

QC 44-292

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)
  • stomach bleeding warning applies to you

  • you have a history of stomach problems, such as heartburn
  • you are taking a diuretic

  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke

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

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
    • slurred speech

    • leg swelling
    • trouble breathing

    • weakness in one part or side of body

  • 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.

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

Ibuprofen USP, 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)
  • 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


Advanced Ingredient Data


Raw Label Data

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