Topco Ibuprofen Capsules

Topco Ibuprofen Capsules
SPL v6
SPL
SPL Set ID c6297c23-3b27-c0c6-e053-2995a90a3e76
Route
ORAL
Published
Effective Date 2025-10-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Fd&c Blue No. 1 Gelatin Polyethylene Glycol, Unspecified Potassium Hydroxide Water Sorbitan Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: IB1 Shape: capsule Color: blue Size: 20 mm Score: 1
Marketing Status
ANDA Active Since 2021-07-02

Description

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)* (present as the free acid and potassium salt) *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/Fever reducer


Medication Information

Purpose

Pain reliever/Fever reducer

Description

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)* (present as the free acid and potassium salt) *nonsteroidal anti-inflammatory drug

Uses
  • temporarily relieves minor aches and pains due to:
  • headache
  • toothache
  • backache
  • menstrual cramps
  • the common cold
  • muscular aches
  • minor pain of arthritis
  • temporarily reduces fever
Section 42229-5

All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Advil ®LIQUI-GELS ®.

DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “ SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

©TOPCO BMAA0521

QUESTIONS? 1-888-423-0139

[email protected] www.topcarebrand.com

Visit here for more information:

http://topbrnds.com/48zzqs

R0622

L0000638

For India Manufacturing Site:

MADE IN INDIA

Code: TN/DRUGS/TN/25/00074

P3413/00/25

L0001119 R0725

Warnings

Ask your doctor before use if you are pregnant, under a doctor’s care for a serious condition, age 60 or over, taking any other drug or have stomach problems.

■ This product 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.

Do not usethis product if you have ever had an allergic reaction to any pain reliever/fever reducer.

20's Label

+TopCare®

health

NDC 36800-193-11

Ibuprofen

Capsules, 200 mg

Pain Reliever • Fever Reducer (NSAID)

20 Softgels**

**Liquid Filled Capsules

actual size

Directions
  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 capsule, 2 capsules may be used
  • do not exceed 6 capsules 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
  • each capsule contains: potassium 20 mg
  • read all warnings and directions before use. Keep carton.
  • store at 20° to 25°C (68° to 77°F)
  • avoid excessive heat above 40°C (104°F). Protect from light.
Inactive Ingredients

FD&C Blue #1, gelatin, glycerin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan and sorbitol

For India Manufacturing Site:

FD&C Blue #1, gelatin, polyethylene glycol,potassium hydroxide, purified water, sorbitan and sorbitol

Questions Or Comments?

call toll free 1-888-423-0139

When Using This Product
  • take with food or milk if stomach upset occurs
80's Label Made in India

+TopCare®

health

NDC 36800-193-78

COMPARE TO THE ACTIVE

INGREDIENT IN ADVIL LIQUI-GELS

Ibuprofen

Capsules, 200 mg

Pain Reliever • Fever Reducer (NSAID)

80 Softgels**

**Liquid Filled Capsules

actual size

Ask A Doctor Before Use If
  • stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • 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 delivery 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 Capsule)

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*







(present as the free acid and potassium salt)







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

All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Advil ®LIQUI-GELS ®.

DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “ SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

©TOPCO BMAA0521

QUESTIONS? 1-888-423-0139

[email protected] www.topcarebrand.com

Visit here for more information:

http://topbrnds.com/48zzqs

R0622

L0000638

For India Manufacturing Site:

MADE IN INDIA

Code: TN/DRUGS/TN/25/00074

P3413/00/25

L0001119 R0725

Purpose

Pain reliever/Fever reducer

Warnings

Ask your doctor before use if you are pregnant, under a doctor’s care for a serious condition, age 60 or over, taking any other drug or have stomach problems.

■ This product 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.

Do not usethis product if you have ever had an allergic reaction to any pain reliever/fever reducer.

20's Label (20's label)

+TopCare®

health

NDC 36800-193-11

Ibuprofen

Capsules, 200 mg

Pain Reliever • Fever Reducer (NSAID)

20 Softgels**

**Liquid Filled Capsules

actual size

Directions
  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 capsule, 2 capsules may be used
  • do not exceed 6 capsules 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)
  • each capsule contains: potassium 20 mg
  • read all warnings and directions before use. Keep carton.
  • store at 20° to 25°C (68° to 77°F)
  • avoid excessive heat above 40°C (104°F). Protect from light.
Inactive Ingredients (Inactive ingredients)

FD&C Blue #1, gelatin, glycerin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan and sorbitol

For India Manufacturing Site:

FD&C Blue #1, gelatin, polyethylene glycol,potassium hydroxide, purified water, sorbitan and sorbitol

Questions Or Comments? (Questions or comments?)

call toll free 1-888-423-0139

When Using This Product (When using this product)
  • take with food or milk if stomach upset occurs
80's Label Made in India (80's label-Made in India)

+TopCare®

health

NDC 36800-193-78

COMPARE TO THE ACTIVE

INGREDIENT IN ADVIL LIQUI-GELS

Ibuprofen

Capsules, 200 mg

Pain Reliever • Fever Reducer (NSAID)

80 Softgels**

**Liquid Filled Capsules

actual size

Ask A Doctor Before Use If (Ask a doctor before use if)
  • stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • 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 delivery 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 Capsule) (Active ingredient (in each capsule))

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*







(present as the free acid and potassium salt)







*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

All Sections (JSON)