ACTROGEL- ibuprofen capsule, liquid filled 
Belmora LLC

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Actrogel 44-754

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

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

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

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 are taking a diuretic
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke

Ask a doctor or pharmacist before use if you are

  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • under a doctor’s care for any serious condition
  • taking any other drug

When using this product

  • take with food or milk if stomach upset occurs

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
    • vomit blood
    • have bloody or black stools
    • feel faint
    • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke:
    • chest pain
    • trouble breathing
    • leg swelling
    • slurred speech
    • weakness in one part or side of body
  • 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

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.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

FD&C blue #1, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan, sorbitol

Questions or comments?

Call 1-888-779-2877 M-F 9AM-5PM EST

Principal display panel

Belmora LLC

NDC 27854-222-00

Actrogel
IBUPROFEN

Solubilized Ibuprofen Capsules, 200 mg
PAIN RELIEVER/FEVER REDUCER
(NSAID)

24
Liquid-filled
CAPSULES

Actual Size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by Belmora LLC
3033 Wilson Blvd.Suite 700
Arlington, VA 22201

Actrogel 44-754

Actrogel 44-754

ACTROGEL 
ibuprofen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27854-222
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
WATER (UNII: 059QF0KO0R)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorblueScoreno score
ShapeOVALSize20mm
FlavorImprint Code IB1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:27854-222-001 in 1 CARTON07/06/2022
124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07868207/06/2022
Labeler - Belmora LLC (112753244)

Revised: 7/2023
Document Id: 3a7d51b5-7cc9-4a46-9bb9-ff212104ec29
Set id: 65ee0aec-1100-46fd-b64e-bee250c5b103
Version: 2
Effective Time: 20230724
 
Belmora LLC