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NDC 36800-0583-34 topcare loperamide hydrochloride 1 mg/7.5mL Details
topcare loperamide hydrochloride 1 mg/7.5mL
topcare loperamide hydrochloride is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is LOPERAMIDE HYDROCHLORIDE.
MedlinePlus Drug Summary
Nonprescription (over-the-counter) loperamide is used to control acute diarrhea (loose stools that come on suddenly and usually lasts less than 2 weeks), including travelers' diarrhea. Prescription loperamide is also used to control acute diarrhea and also ongoing diarrhea associated with inflammatory bowel disease (IBD; condition in which the lining of all or part of the intestine is swollen, irritated, or has sores). Prescription loperamide is also used to reduce the amount of fluid in people with ileostomies (surgery to create an opening for waste to leave the body through the abdomen). Loperamide is in a class of medications called antidiarrheal agents. It works by decreasing the flow of fluids and electrolytes into the bowel and by slowing down the movement of the bowel to decrease the number of bowel movements.
Related Packages: 36800-0583-34Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Loperamide
Product Information
| NDC | 36800-0583 |
|---|---|
| Product ID | 36800-583_6800c4b3-c705-4b77-82bd-64da73b92600 |
| Associated GPIs | 47100020102005 |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | topcare loperamide hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | loperamide HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 1 |
| Active Ingredient Units | mg/7.5mL |
| Substance Name | LOPERAMIDE HYDROCHLORIDE |
| Labeler Name | Topco Associates LLC |
| Pharmaceutical Class | Opioid Agonist [EPC], Opioid Agonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA091292 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 36800-0583-34 (36800058334)
| NDC Package Code | 36800-583-34 |
|---|---|
| Billing NDC | 36800058334 |
| Package | 240 mL in 1 BOTTLE (36800-583-34) |
| Marketing Start Date | 2022-09-16 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 1cd497b4-d97e-447a-9251-710d2fddbf23 Details
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
Ask a doctor before use if you have
- •
- fever
- •
- mucus in the stool
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- a history of liver disease
- •
- a history of abnormal heart rhythm
Ask a doctor or pharmacist before use if you are
taking a prescription drug. Loperamide may interact with certain prescription drugs.
When using this product
tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.
Directions
- •
- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
- •
- find right dose on chart. If possible, use weight to dose; otherwise use age.
- •
- shake well before using
- •
- use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
- •
- mL = milliliter
|
adults and children 12 years and over |
30 mL after the first loose stool; 15 mL after each subsequent loose stool; but no more than 60 mL in 24 hours |
|
children 9-11 years (60-95 lbs) |
15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hours |
|
children 6-8 years (48-59 lbs) |
15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL in 24 hours |
|
children 2-5 years (34 to 47 lbs) |
ask a doctor |
|
children under 2 years (up to 33 lbs) |
do not use |
Inactive ingredients
Package/Label Principal Display Panel
INGREDIENTS AND APPEARANCE
| TOPCARE LOPERAMIDE HYDROCHLORIDE
loperamide hcl solution |
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| Labeler - Topco Associates LLC (006935977) |