Proprinal

Proprinal
SPL v2
SPL
SPL Set ID ec27b625-a3fa-4c5f-8134-c9373c09b3e3
Route
ORAL
Published
Effective Date 2023-08-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: 133 Shape: capsule Color: green Size: 19 mm Score: 1
Marketing Status
ANDA Active Since 2017-01-11

Description

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


Medication Information

Warnings and Precautions

Warnings

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

  • hives
  • blisters
  • shock
  • facial swelling
  • asthma (wheezing)
  • rash
  • skin reddening

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 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

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.

Indications and Usage

Uses:

Temporarily relieves minor aches and pains due to:

  • headache
  • muscular aches
  • backache
  • minor arthritis pain
  • the common cold
  • toothache
  • menstrual cramps

Temporarily reduces fever

Dosage and Administration

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 take more than 6 capsules in 24 hours, unless directed by a doctor

children under 12 years of age : ask a doctor

Description

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

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 50566-9

Stop use and ask a doctor if

  • an allergic reaction occurs, seek medical help right away
  • fever worsens or lasts more than 3 days
  • pain worsens or lasts more than 10 days
  • you have any of the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, or stomach pain that does not get better
  • new symptoms occur
  • redness or swelling is present
  • you have symptoms of heart problems or stroke: chest pain, trouble breathing, weakness in one part or side of the body, slurred speech, or leg swelling

Section 50567-7

When using this produc take with food or milk if stomach upset occurs

Section 50568-5

Ask a doctor or pharmacist before use if you

  • are under a doctor's care for any serious condition
  • take aspirin for heart attack or stroke (ibuprofen may decrease this benefit of aspirin)
  • take any other drug
Section 50569-3

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
Section 50570-1

Do not use

  • if you have ever had an allergic reaction to any pain reliever/fever reducer
  • right before or after heart surgery
Section 51727-6

Inactive ingredients Ammonium hydroxide, FD&C green #3, gelatin, iron oxide black, medium chain triglycerides, polyethylene glycol, propylene glycol, potassium hydroxide, purified water, shellac, sorbitan monooleate, sorbitol sorbitan

Section 51945-4

Section 53414-9

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.

Section 55105-1

Purpose

Pain reliever/Fever reducer

Section 55106-9

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

Other Information

Other information

  • each capsule contains: potassium 20 mg
  • caplets enclosed in a sealed packet

  • do not use if packet is torn, cut or open
  • store at 59° to 86°F (15°-30°C)
  • avoid excessive heat and humidity


Structured Label Content

Indications and Usage (34067-9)

Uses:

Temporarily relieves minor aches and pains due to:

  • headache
  • muscular aches
  • backache
  • minor arthritis pain
  • the common cold
  • toothache
  • menstrual cramps

Temporarily reduces fever

Dosage and Administration (34068-7)

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 take more than 6 capsules in 24 hours, unless directed by a doctor

children under 12 years of age : ask a doctor

Warnings and Precautions (34071-1)

Warnings

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

  • hives
  • blisters
  • shock
  • facial swelling
  • asthma (wheezing)
  • rash
  • skin reddening

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 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

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.

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 50566-9 (50566-9)

Stop use and ask a doctor if

  • an allergic reaction occurs, seek medical help right away
  • fever worsens or lasts more than 3 days
  • pain worsens or lasts more than 10 days
  • you have any of the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, or stomach pain that does not get better
  • new symptoms occur
  • redness or swelling is present
  • you have symptoms of heart problems or stroke: chest pain, trouble breathing, weakness in one part or side of the body, slurred speech, or leg swelling

Section 50567-7 (50567-7)

When using this produc take with food or milk if stomach upset occurs

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you

  • are under a doctor's care for any serious condition
  • take aspirin for heart attack or stroke (ibuprofen may decrease this benefit of aspirin)
  • take any other drug
Section 50569-3 (50569-3)

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
Section 50570-1 (50570-1)

Do not use

  • if you have ever had an allergic reaction to any pain reliever/fever reducer
  • right before or after heart surgery
Section 51727-6 (51727-6)

Inactive ingredients Ammonium hydroxide, FD&C green #3, gelatin, iron oxide black, medium chain triglycerides, polyethylene glycol, propylene glycol, potassium hydroxide, purified water, shellac, sorbitan monooleate, sorbitol sorbitan

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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.

Section 55105-1 (55105-1)

Purpose

Pain reliever/Fever reducer

Section 55106-9 (55106-9)

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

Other Information (OTHER INFORMATION)

Other information

  • each capsule contains: potassium 20 mg
  • caplets enclosed in a sealed packet

  • do not use if packet is torn, cut or open
  • store at 59° to 86°F (15°-30°C)
  • avoid excessive heat and humidity


Advanced Ingredient Data


Raw Label Data

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