FDA Label for Proprinal
View Indications, Usage & Precautions
Proprinal Product Label
The following document was submitted to the FDA by the labeler of this product Hart Health. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
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
Otc - Purpose
Purpose
Pain reliever/Fever reducer
Indications & 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
Warnings
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
- 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
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:
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.
Otc - Do Not Use
Do not use
- if you have ever had an allergic reaction to any pain reliever/fever reducer
- right before or after heart surgery
Otc - Ask Doctor
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
Otc - Ask Doctor/Pharmacist
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
Otc - When Using
When using this produc take with food or milk if stomach upset occurs
Otc - Stop Use
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
Otc - Pregnancy 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.
Otc - 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 (1-800-222-1222).
Dosage & 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
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
Inactive Ingredient
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
* Please review the disclaimer below.