DOLEX FLEX- ibuprofen capsule, liquid filled 
Pharmadel LLC

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DOLEX FLEX (HLife)

Drug Facts

Active Ingredient & Purposes

Active ingredient (in each capsule)Purposes
Solubilized ibuprofen equal to
200 mg ibuprofen (NSAID*).............................

(present as the free acid and potassium salt)

* nonsteroidal anti-inflammatory drug

Pain reliever/ fever reducer

Uses

Warnings

Allergy alert:

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

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

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

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

Ask a doctor or pharmacist before use if you are

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

When using this product

  • take with food or milk if stomach upset occurs

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

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 exceed 6 capsules in 24 hours, unless directed by a doctor

children under 12 years

  • ask a doctor

Other information

Inactive ingredients

FD&C blue no.1, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitol, and sorbitan

Questions or comments?

1-866-359-3478
(M-F) 9 AM - 5 PM EST or www.pharmadel.com

Package Principal Display Panel

Dolex Flex PDP

DOLEX FLEX 
ibuprofen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-014
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SORBITAN (UNII: 6O92ICV9RU)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
WATER (UNII: 059QF0KO0R)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
SORBITOL (UNII: 506T60A25R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
GELATIN (UNII: 2G86QN327L)  
Product Characteristics
ColorblueScorescore with uneven pieces
ShapeOVALSize20mm
FlavorImprint Code IB1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55758-014-201 in 1 CARTON09/07/2023
120 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:55758-014-9950 in 1 CARTON11/01/2023
2NDC:55758-014-022 in 1 PACKET; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07868209/01/2023
Labeler - Pharmadel LLC (030129680)

Revised: 10/2023
Document Id: 09086612-90a7-f548-e063-6294a90aa5e0
Set id: 0543420d-a250-065d-e063-6294a90a005e
Version: 2
Effective Time: 20231031
 
Pharmadel LLC