Label: PROPRINAL- ibuprofen capsules 200 mg capsule, liquid filled
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NDC Code(s):
50332-0130-1,
50332-0130-3,
50332-0130-4,
50332-0130-7, view more50332-0130-8
- Packager: HART Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 11, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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
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.
- DO NOT USE
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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
- ASK DOCTOR/PHARMACIST
- WHEN USING
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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
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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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
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PROPRINAL
ibuprofen capsules 200 mg capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50332-0130 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SHELLAC (UNII: 46N107B71O) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) AMMONIA (UNII: 5138Q19F1X) GELATIN (UNII: 2G86QN327L) FERROSOFERRIC OXIDE (UNII: XM0M87F357) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) SORBITOL (UNII: 506T60A25R) Product Characteristics Color green Score no score Shape CAPSULE Size 19mm Flavor Imprint Code 133 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50332-0130-3 20 in 1 BAG 01/11/2017 1 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:50332-0130-4 40 in 1 BOX 01/11/2017 2 2 in 1 PACKET; Type 0: Not a Combination Product 3 NDC:50332-0130-7 100 in 1 BOX 01/11/2017 3 2 in 1 PACKET; Type 0: Not a Combination Product 4 NDC:50332-0130-8 200 in 1 BOX 01/11/2017 4 2 in 1 PACKET; Type 0: Not a Combination Product 5 NDC:50332-0130-1 300 in 1 BOX 01/11/2017 5 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079205 01/11/2017 Labeler - HART Health (069560969)