Ibuprofen Capsules 200 Mg

Ibuprofen Capsules 200 Mg
SPL v2
SPL
SPL Set ID 58bff8bf-5a4e-4390-9c03-e266d31deb6b
Route
ORAL
Published
Effective Date 2019-11-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Fd&c Green No. 3 Gelatin Medium-chain Triglycerides Polyethylene Glycol, Unspecified Potassium Hydroxide Sorbitan Sorbitol Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2017-07-13

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 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 53414-9

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.

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
  • blister
If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains an 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 blood thinning (anticoagulant) or steroid drug
  • 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
  • take more or for a longer time 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 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°-25°C (68°-77°F)
  • avoid excessive heat above 40°C (104°F)
Inactive Ingredients

FD&C green #3, gelatin, medium chain triglycerides, polyethylene glycol, potassium hydroxide, purified water, sorbitol sorbitan solution, and white edible ink

Questions Or Commonts

Call toll free: 1-855-215-8180

When Using This Product
  • take with food or milk if stomach upset occurs
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
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, or asthma
  • 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
  • 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
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

Principal Display Panel Shipper Label

Ibuprofen Capsules 200mg, 20ct

Quantity: 35 Bottles

NDC No.:53345-014-02

MADE IN CHINA

IMPORTANT:

1.Inspect immediately upon receipt.

2.This is a bulk shipment, intended for further processing only.

3.Protect from heat, humidity, and light. Do not refrigerate.

4.Store at 20-25°C (68-77)°F

Ask A Doctor Or Pharmacist Before Use If You Are
  • under a doctor's care for any serious conditon
  • 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 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 53414-9 (53414-9)

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.

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
  • blister
If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains an 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 blood thinning (anticoagulant) or steroid drug
  • 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
  • take more or for a longer time 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 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°-25°C (68°-77°F)
  • avoid excessive heat above 40°C (104°F)
Inactive Ingredients (Inactive ingredients)

FD&C green #3, gelatin, medium chain triglycerides, polyethylene glycol, potassium hydroxide, purified water, sorbitol sorbitan solution, and white edible ink

Questions Or Commonts (Questions or commonts)

Call toll free: 1-855-215-8180

When Using This Product (When using this product)
  • take with food or milk if stomach upset occurs
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
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, or asthma
  • 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
  • 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
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

Principal Display Panel Shipper Label (PRINCIPAL DISPLAY PANEL - Shipper Label)

Ibuprofen Capsules 200mg, 20ct

Quantity: 35 Bottles

NDC No.:53345-014-02

MADE IN CHINA

IMPORTANT:

1.Inspect immediately upon receipt.

2.This is a bulk shipment, intended for further processing only.

3.Protect from heat, humidity, and light. Do not refrigerate.

4.Store at 20-25°C (68-77)°F

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 conditon
  • 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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