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NDC 36800-0224-53 topcare anti diarrheal 2 mg/1 Details
topcare anti diarrheal 2 mg/1
topcare anti diarrheal is a ORAL TABLET, FILM COATED 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: 36800-0224-53Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Loperamide
Product Information
| NDC | 36800-0224 |
|---|---|
| Product ID | 36800-224_f208e8d5-90a0-4c10-a15c-d9a8c3d76d26 |
| 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 | topcare anti diarrheal |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Loperamide Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 2 |
| Active Ingredient Units | mg/1 |
| 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 | ANDA075232 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 36800-0224-53 (36800022453)
| NDC Package Code | 36800-224-53 |
|---|---|
| Billing NDC | 36800022453 |
| Package | 12 BLISTER PACK in 1 CARTON (36800-224-53) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
| Marketing Start Date | 2003-02-26 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL da347b47-d8a5-4cf9-9579-79e6fe57fed5 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 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.
|
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
Principal Display Panel
INGREDIENTS AND APPEARANCE
| TOPCARE ANTI DIARRHEAL
loperamide hydrochloride tablet, film coated |
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| Labeler - Topco Associates LLC (006935977) |