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NDC 73581-0101-24 WELMATE Anti Diarrheal Loperamide HCl 2 mg/1 Details
WELMATE Anti Diarrheal Loperamide HCl 2 mg/1
WELMATE Anti Diarrheal Loperamide HCl is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by YYBA CORP. 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: 73581-0101-24Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Loperamide
Product Information
| NDC | 73581-0101 |
|---|---|
| Product ID | 73581-101_ae2e0cfe-f5ab-d20f-e053-2995a90a5237 |
| Associated GPIs | |
| 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 | WELMATE Anti Diarrheal Loperamide HCl |
| 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 | YYBA CORP |
| Pharmaceutical Class | Opioid Agonist [EPC], Opioid Agonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA076497 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 73581-0101-24 (73581010124)
| NDC Package Code | 73581-101-24 |
|---|---|
| Billing NDC | 73581010124 |
| Package | 4 BLISTER PACK in 1 CARTON (73581-101-24) / 6 TABLET in 1 BLISTER PACK |
| Marketing Start Date | 2020-08-22 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL ae2e006c-0347-6c35-e053-2a95a90ab7b1 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
- a history of liver disease
- a history of abnormal heart rhythm
- Ask a doctor 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.
| adults and children 12 years and over | 2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours |
| children 9-11 years (60-95 lbs) | 1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours |
| children 6-8 years (48-59 lbs) | 1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets 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
INGREDIENTS AND APPEARANCE
| WELMATE ANTI DIARRHEAL LOPERAMIDE HCL
loperamide hydrochloride tablet |
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| Labeler - YYBA CORP (006339772) |