Probiotics - oral
Controlled Del Probiotic 126 mg (2 billion cell) tablet,extend release
Probiotics contain different types of micro-organisms such as yeast (saccharomyces boulardii) and bacteria (such as lactobacillus, bifidobacterium). Micro-organisms (flora) are naturally found in the stomach/intestines/vagina. Some conditions (such as antibiotic use, travel) can change the normal balance of bacteria/yeast. Probiotics are used to improve digestion and restore normal flora.
Probiotics have been used to treat bowel problems (such as diarrhea, irritable bowel), eczema, vaginal yeast infections, lactose intolerance, and urinary tract infections.
Probiotics are available in foods (such as yogurt, milk, juices, soy beverages) and as dietary supplements (capsules, tablets, powders). Different products have different uses. Check the label for information on uses for your particular product.
Some diet supplement products have been found to contain possibly harmful impurities/additives. Check with your pharmacist for more details regarding the particular brand you use.
The FDA has not reviewed this product for safety or effectiveness. Consult your doctor or pharmacist for more details.
Follow all directions on the product package. Refer to the label directions for your specific product to see if the dose should be swallowed whole, chewed, sprinkled onto food or mixed with liquid. If you are uncertain about any of the information, consult your doctor or pharmacist.
Some probiotic products may contain live bacteria (such as bifidobacteria). Antibiotics may prevent these products from working well. Take any product containing live bacteria at least 2 to 3 hours before or after taking antibiotics. Follow the directions for your specific product.
If you are taking this product for diarrhea due to antibiotics, do not use it if you have a high fever or for more than 2 days, unless directed by your doctor. You may have a serious problem that requires medical treatment.
If your condition persists or worsens, or if you think you may have a serious medical problem, seek immediate medical attention.
An increase in stomach gas or bloating may occur. If this effect persists or worsens, notify your doctor or pharmacist promptly.
Tell your doctor right away if any of these unlikely but serious side effects occur:
- signs of infection (such as high fever, chills, persistent cough)
A very serious allergic reaction to this product is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction:
- itching/swelling (especially of the face/tongue/throat)
- severe dizziness
- trouble breathing
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before using this product, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
If you have any of the following health problems, consult your doctor or pharmacist before using this product:
- diarrhea lasting more than 2 days (especially if you also have a high fever)
- weakened immune system (such as due to chemotherapy, HIV infection)
- recurring vaginal infections
- recurring urinary tract infections
Liquid products, foods, powders, or chewable tablets may contain sugar and/or aspartame. Caution is advised if you have diabetes, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
During pregnancy, this product should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is unknown whether this product passes into breast milk. Consult your doctor before breast-feeding.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Some medications that may interact with certain probiotics include:
- antifungals (such as clotrimazole, ketoconazole, griseofulvin, nystatin)
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Keep all regular medical and laboratory appointments.
Some brands may also contain other ingredients, such as fiber or inulin. Ask your doctor or pharmacist if you have questions about the ingredients in your brand.
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
Different types of probiotics may have different storage needs. Some may require refrigeration while others should not be refrigerated. Check the product package for instructions on how to store your product. If you have any questions about storage, ask your pharmacist. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Information last revised June 2018.
Copyright(c) 2018 First Databank, Inc.
Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.
The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.