Otc - Purpose
| Active ingredient (in each capsule) | Purpose |
| Solubilized ibuprofen equal to
200 mg ibuprofen (NSAID)*............... | Pain reliever/fever reducer |
* nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Pharmadel Llc for the product Dolex Flex (NDC 55758-310). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - purpose, uses, allergy alert:, stomach bleeding warning:, heart attack and stroke warning:, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
| Active ingredient (in each capsule) | Purpose |
| Solubilized ibuprofen equal to
200 mg ibuprofen (NSAID)*............... | Pain reliever/fever reducer |
* nonsteroidal anti-inflammatory drug
Temporarily relieves minor aches and pains due to:
Ibuprofen may cause a severeallergic reaction, especially in people allergic to aspirin. Symptoms may include:
If an allergic reaction occurs, stop use and seek
medical help right away.
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
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.
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 (1-800-222-1222).
In case of overdose, get medical help or contact a Poison Control Center right away.
FD&C blue no. 1, FD&C, yellow no.6, gelatin, lecithin (soybean), medium-chain triglycerides, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitol sobitan.
1-866-359-3478
(M-F) 9 AM - 5 PM EST or www.pharmadel.com
DOLEX® FLEX
Relief of
MUSCULAR ACHES
Solubilized Ibuprofen Capsules, 200 mg
Pain Reliever / Fever Reducer (NSAID)
20 SOFTGELS**
(**Liquid Filled Capsules)
* Please review the disclaimer below.