Label: DOLEX FLEX- ibuprofen capsule, liquid filled
- NDC Code(s): 55758-014-02, 55758-014-20, 55758-014-99
- Packager: Pharmadel LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 31, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient & Purposes
- 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
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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 exceed 6 capsules in 24 hours, unless directed by a doctor
children under 12 years
- ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
- Package Principal Display Panel
-
INGREDIENTS AND APPEARANCE
DOLEX FLEX
ibuprofen capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55758-014 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 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 Color blue Score score with uneven pieces Shape OVAL Size 20mm Flavor Imprint Code IB1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55758-014-20 1 in 1 CARTON 09/07/2023 1 20 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:55758-014-99 50 in 1 CARTON 11/01/2023 2 NDC:55758-014-02 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 ANDA078682 09/01/2023 Labeler - Pharmadel LLC (030129680)
