RxNorm Names
LOPERAMIDE HCL
(loperamide hydrochloride)
capsule, liquid filled
[Chain Drug Consortium, LLC]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4e1ea9c9-031f-4b78-ac21-27bdc7683139| Category | DEA Schedule | Marketing Status |
|---|---|---|
| HUMAN OTC DRUG LABEL | New Drug Application |
Warnings
Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCl
When using this product
tiredness, drowsiness, or dizziness may occur. Be careful when driving or operating machinery.
Stop use and ask 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.
- side effects occur. You may want to report side effects to FDA at 1800-FDA-1088.
Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center right away.
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 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels in 24 hours
Other information
- do not use if carton or blister unit is open or torn
- store at 20-25°C (68-77°F)
- avoid excessive heat above 40°C (104°F).
- see side panel for lot number and expiration date
- use the 1 mg soft gelatin capsule product for children 6 to under 12 years of age
Inactive ingredients
Butylated hydroxyanisole, edible ink FDandC blue #1, Gelatin, Glycerin, Glyceryl Caprylate, Polyoxyl 40 hydrogenated castor oil and purified water.Product Labeling
Premier ValueCompare to the active ingredient in Imodium(r) A-D
Anti-Diarrheal
Loperamide HCl
Soft gelatin capsules, 2mg
Controls the Symptoms of Diarrhea
suitable for adults and children 12 years and over
12 softgels
Distributed by: Chan Drug Consortium, LLC
3301 NW Boca Raton Blvd. Suite 101
Boca Raton, FL 33431
Manufactured by
Banner Pharmacaps, Inc.
4215 Premier Drive
High Point, NC 27265
**This product is not manufactured or distributed by McNeil Consumer and Specialty Pharmaceuticals, owner of ther egistered trademark of Imodium (r) A-D.

| LOPERAMIDE HCL
loperamide hydrochloride capsule, liquid filled |
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| Labeler - Chain Drug Consortium, LLC (101668460) |
Revised: 12/2012
Document Id: 47bff05d-dc66-42fd-a9c2-c15d275167c7
Set id: 4e1ea9c9-031f-4b78-ac21-27bdc7683139
Version: 2
Effective Time: 20121205
Chain Drug Consortium, LLC
Review RxNorm Normal Forms