Topcare 44-292

Topcare 44-292
SPL v13
SPL
SPL Set ID 59a88ca7-eb37-46de-9134-a5a6d330bd49
Route
ORAL
Published
Effective Date 2025-06-11
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 Active Since 1988-05-24

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:
    • headache
    • muscular aches
    • menstrual cramps
    • backache
    • toothache
    • 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:

  • 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

  • have had stomach ulcers or bleeding problems
  • are age 60 or older
  • take a blood thinning (anticoagulant) or steroid drug
  • take more or for a longer time than directed
  • 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

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)
  • use by expiration date on package
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 1-888-423-0139

Principal Display Panel

+TopCare ®

health

NDC 36800-292-06

COMPARE TO ADVIL® CAPLETS

ACTIVE INGREDIENT

Ibuprofen

Tablets USP, 200 mg

• PAIN RELIEVER

• FEVER REDUCER

  (NSAID)

200 CAPLETS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007

©TOPCO LNKA0521 QUESTIONS? 1-888-423-0139

[email protected] www.topcarebrand.com

Visit here for more information: http://topbrnds.com/48ZZSM

This product is not manufactured or

distributed by PF Consumer

Healthcare 1 LLC, owner of the

registered trademark Advil® Caplets.

50844          REV1221C29206

TopCare 44-292
When Using This Product
  • take with food or milk if stomach upset occurs
Ask A Doctor Before Use If
  • you are taking a diuretic
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have a history of stomach problems, such as heartburn
  • stomach bleeding warning applies to you
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
Stop Use and Ask A Doctor If
  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • have bloody or black stools
    • vomit blood
    • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke:
    • chest pain
    • weakness in one part or side of body
    • leg swelling
    • trouble breathing
    • slurred speech
  • 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:
    • headache
    • muscular aches
    • menstrual cramps
    • backache
    • toothache
    • 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:

  • 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

  • have had stomach ulcers or bleeding problems
  • are age 60 or older
  • take a blood thinning (anticoagulant) or steroid drug
  • take more or for a longer time than directed
  • 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

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)
  • use by expiration date on package
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 1-888-423-0139

Principal Display Panel

+TopCare ®

health

NDC 36800-292-06

COMPARE TO ADVIL® CAPLETS

ACTIVE INGREDIENT

Ibuprofen

Tablets USP, 200 mg

• PAIN RELIEVER

• FEVER REDUCER

  (NSAID)

200 CAPLETS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007

©TOPCO LNKA0521 QUESTIONS? 1-888-423-0139

[email protected] www.topcarebrand.com

Visit here for more information: http://topbrnds.com/48ZZSM

This product is not manufactured or

distributed by PF Consumer

Healthcare 1 LLC, owner of the

registered trademark Advil® Caplets.

50844          REV1221C29206

TopCare 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)
  • you are taking a diuretic
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have a history of stomach problems, such as heartburn
  • stomach bleeding warning applies to you
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
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
    • have bloody or black stools
    • vomit blood
    • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke:
    • chest pain
    • weakness in one part or side of body
    • leg swelling
    • trouble breathing
    • slurred speech
  • 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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