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NDC 66424-0735-96 ANTI-DIARRHEAL LOPERAMIDE HCL, 2 mg caplets 2 mg/1 Details
ANTI-DIARRHEAL LOPERAMIDE HCL, 2 mg caplets 2 mg/1
ANTI-DIARRHEAL LOPERAMIDE HCL, 2 mg caplets is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by SDA Laboratories, Inc.. 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: 66424-0735-96Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Loperamide
Product Information
| NDC | 66424-0735 |
|---|---|
| Product ID | 66424-735_6c8fecaf-a018-4cb5-b48a-d66eb489a58c |
| 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 | ANTI-DIARRHEAL LOPERAMIDE HCL, 2 mg caplets |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Loperamide HCL |
| 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 | SDA Laboratories, Inc. |
| Pharmaceutical Class | Opioid Agonist [EPC], Opioid Agonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA076497 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 66424-0735-96 (66424073596)
| NDC Package Code | 66424-735-96 |
|---|---|
| Billing NDC | 66424073596 |
| Package | 96 TABLET in 1 BOTTLE, PLASTIC (66424-735-96) |
| Marketing Start Date | 2019-03-28 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL e3d4f789-d41c-4965-975b-5af743d7b8e3 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.
Do not use if you have bloody or black stool
Ask a doctor before use if you have • fever • mucus in the stool • a history of liver disease
Ask a doctor or pharmacist before use if you are taking antibiotics
When using this product tiredness, drowsiness, or dizziness may occur. Be careful when driving or operating machinery.
Stop use and ask a doctor if • symptoms get worse • diarrhea lasts more than 2 days • you get abdominal swelling or bulging. These may be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Directions
- drink plenty of clear liquids to help prevent dehydration caused by diarrhea
- find the right dose on the 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 under 6 years (up to 47 lbs) | ask a doctor |
Inactive ingredients
SPL UNCLASSIFIED SECTION
Compare to the active ingredient in Imodium® A-D†
ORIGINAL PRESCRIPTION STRENGTH
CONTROLS SYMPTOMS OF DIARRHEA
DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED
†This product is not manufactured or distributed by the owner of the registered trademark of Imodium® A-D.
L.Rev. 08/18
Distributed by:
SDA Laboratories, Inc.
Greenwich, CT 06830
INGREDIENTS AND APPEARANCE
| ANTI-DIARRHEAL LOPERAMIDE HCL, 2 MG CAPLETS
loperamide hcl tablet |
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| Labeler - SDA Laboratories, Inc. (948067889) |
| Registrant - SmartScience Laboratories Inc. (035907919) |