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NDC 58602-0701-01 Loperamide Hydrochloride 2 mg/1 Details
Loperamide Hydrochloride 2 mg/1
Loperamide Hydrochloride is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Aurohealth 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: 58602-0701-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Loperamide
Product Information
NDC | 58602-0701 |
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Product ID | 58602-701_0ea6d174-57a9-419a-b16b-40404087d1a8 |
Associated GPIs | 47100020100305 |
GCN Sequence Number | 013672 |
GCN Sequence Number Description | loperamide HCl TABLET 2 MG ORAL |
HIC3 | D6D |
HIC3 Description | ANTIDIARRHEALS |
GCN | 08550 |
HICL Sequence Number | 001236 |
HICL Sequence Number Description | LOPERAMIDE HCL |
Brand/Generic | Generic |
Proprietary Name | Loperamide Hydrochloride |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Loperamide Hydrochloride |
Product Type | HUMAN OTC DRUG |
Dosage Form | TABLET |
Route | ORAL |
Active Ingredient Strength | 2 |
Active Ingredient Units | mg/1 |
Substance Name | LOPERAMIDE HYDROCHLORIDE |
Labeler Name | Aurohealth LLC |
Pharmaceutical Class | Opioid Agonist [EPC], Opioid Agonists [MoA] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA206548 |
Listing Certified Through | 2024-12-31 |
Package
Package Images

NDC 58602-0701-01 (58602070101)
NDC Package Code | 58602-701-01 |
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Billing NDC | 58602070101 |
Package | 1 BLISTER PACK in 1 CARTON (58602-701-01) / 6 TABLET in 1 BLISTER PACK |
Marketing Start Date | 2015-12-15 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL f3ea8779-252e-4038-ae41-500e15c54825 Details
Warnings
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are
When using this product
Stop use and ask a doctor if
Keep out of reach of children.
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.
adults and children 12 years and over | 2 tablets after the first loose stool; 1 tablet after each subsequent loose stool; but no more than 4 tablets in 24 hours |
children 9 to 11 years (60 to 95 lbs) | 1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 3 tablets in 24 hours |
children 6 to 8 years (48 to 59 lbs) | 1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 2 tablets in 24 hours |
children 2 to 5 years (34 to 47 lbs) | ask a doctor |
children under 2 years (up to 33 lbs) | do not use |
Other information
Inactive ingredients
Questions or comments?
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg Blister Carton (4 x 6's Tablets)
INGREDIENTS AND APPEARANCE
LOPERAMIDE HYDROCHLORIDE
loperamide hydrochloride tablet |
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Labeler - Aurohealth LLC (078728447) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Aurobindo Pharma Limited | 650381903 | ANALYSIS(58602-701) , MANUFACTURE(58602-701) |