PROPRINAL- ibuprofen capsules 200 mg capsule, liquid filled 
HART Health

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PROPRINAL

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

Purpose
Pain reliever/Fever reducer

Uses:

Temporarily relieves minor aches and pains due to:

Temporarily reduces fever

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

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.

Do not use

Ask a doctor before use if

Ask a doctor or pharmacist before use if you

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

Stop use and ask a doctor if

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.

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).

Directions

do not take more than directed​

the smallest effective dose should be used

adults and children 12 years and over:

children under 12 years of age : ask a doctor

OTHER INFORMATION

Other information

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

Proprinal.jpg

PROPRINAL 
ibuprofen capsules 200 mg capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0130
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorgreenScoreno score
ShapeCAPSULESize19mm
FlavorImprint Code 133
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50332-0130-320 in 1 BAG01/11/2017
12 in 1 PACKET; Type 0: Not a Combination Product
2NDC:50332-0130-440 in 1 BOX01/11/2017
22 in 1 PACKET; Type 0: Not a Combination Product
3NDC:50332-0130-7100 in 1 BOX01/11/2017
32 in 1 PACKET; Type 0: Not a Combination Product
4NDC:50332-0130-8200 in 1 BOX01/11/2017
42 in 1 PACKET; Type 0: Not a Combination Product
5NDC:50332-0130-1300 in 1 BOX01/11/2017
52 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07920501/11/2017
Labeler - HART Health (069560969)

Revised: 8/2023
Document Id: 7c3b7649-6dc8-475b-b3a4-fec092ce6fe6
Set id: ec27b625-a3fa-4c5f-8134-c9373c09b3e3
Version: 1
Effective Time: 20230811
 
HART Health