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| Product NDC Code | 63868-876 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Anti-diarrheal |
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| Type | Brand | ||||||
| Pharm Class | Opioid Agonist [EPC], Opioid Agonists [MoA] |
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| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | CAPSULE, LIQUID FILLED | ||||||
| RxCUI drug identifier | 978006 | ||||||
| Application Number | NDA021855 | ||||||
| Labeler Name | CHAIN DRUG MARKETING ASSOCIATION INC. | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each capsule) Loperamide HCl 2 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions drink plenty of clear fluids to help prevent dehydration caused by diarrhea. not for use in children under 12 years of age adults and children 12 years and over: 2 capsules after the first loose stool; 1 capsule after each subsequent loose stool; but no more than 4 capsules in 24 hours
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients butylated hydroxyanisole, edible ink, FD&C Blue #1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil, purified water
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Use controls symptoms of diarrhea, including Travelers' Diarrhea
Purpose
Information about the drug product’s indications for use.Purpose Anti-diarrheal
Spl product data elements
Usually a list of ingredients in a drug product.Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE BUTYLATED HYDROXYANISOLE FD&C BLUE NO. 1 GELATIN GLYCERIN GLYCERYL CAPRYLATE POLYOXYL 40 HYDROGENATED CASTOR OIL WATER LOPERAMIDE HYDROCHLORIDE LOPERAMIDE LP2
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel QC ® QUALITY CHOICE NDC 63868-876-24 *Compare to the Active Ingredient in Imodium ® A-D Anti-Diarrheal Loperamide HCl Soft Gelatin Capsules, 2 mg Controls the Symptoms of Diarrhea Suitable for Adults and Children 12 Years and Over † Each Liquid-Filled Capsule Contains 2 mg Loperamide HCl 24 Softgels † front back
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.THIS PRODUCT IS PACKAGED IN A CHILD-RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. *All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Imodium ® A-D L0000568 Lot # Expiration Date R0322 Distributed by C.D.M.A., Inc.© 43157 W 9 Mile Rd Novi, MI 48375 www.qualitychoice.com Questions: 248-449-9300
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have fever mucus in the stool a history of liver disease a history of abnormal heart rhythm
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use if you have bloody or black stool in children under 12 years of age
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information store at 20°-25°C (68°-77°F). Protect from Light. avoid excessive heat above 40°C (104°F) do not use if carton or blister unit is open or torn see side panel for lot number and expiration date
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? call toll free 1-888-235-2466
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if symptoms get worse diarrhea lasts for more than 2 days you get abdominal swelling or bulging. These may be signs of a serious condition.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product tiredness, drowsiness, or dizziness may occur. Be careful when driving or operating machinery.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCl Heart alert: Taking more than directed can cause serious heart problems or death
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API