Active Ingredients And Purpose
Active ingredient (in each caplet)
Loperamide HCl 2 mg
Purpose
Anti-diarrheal
Quality Plus 44-375 Anti-diarrheal
- Manufacturer
- L.N.K. International, Inc. | LNK International, Inc.
- Effective date
- 2025-06-27
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 23
- Source
- full-release
- Hydrated at
- 2026-06-01 01:06:09
Key Label Information#
Uses
Use
controls symptoms of diarrhea, including Travelers’ Diarrhea
Warnings
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
Directions And Dosage
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
Other Label Information
Other information
each caplet contains: calcium 15 mg TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store between 20º-25ºC (68º-77ºF) see end flap for expiration date and lot number
Inactive ingredients
corn starch, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide
Questions or comments?
Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday
Principal Display Panel
QUALITY + PLUS NDC 50844-375-45 *Compare to active ingredient in Imodium ® A-D ANTI- DIARRHEAL Loperamide HCl Tablets, 2 mg ANTI-DIARRHEAL Controls the symptoms of diarrhea 24 Caplets ACTUAL SIZE TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING *This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Imodium® A-D. 50844 REV0325B37545 Distributed by LNK INTERNATIONAL, INC. 60 Arkay Drive Hauppauge, NY 11788 USA 1. To open, tear 2. Use ✄ to cut at perforations and through plastic remove a section. for caplet. Quality Plus 44-375
Label Images#
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| LOPERAMIDE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 10f838ef-a72b-645d-80f8-e2255205c3b1 | Product name | 6 | 20240805 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50844-375-02 | Anti-diarrheal | 3 in 1 CARTON | TABLET | 3 | 23 | |
| 50844-375-02 | Anti-diarrheal | 4 in 1 BLISTER PACK | TABLET | 4 | 23 | |
| 50844-375-08 | Anti-diarrheal | 4 in 1 CARTON | TABLET | 4 | 23 | |
| 50844-375-08 | Anti-diarrheal | 6 in 1 BLISTER PACK | TABLET | 6 | 23 | |
| 50844-375-45 | Anti-diarrheal | 1 in 1 CARTON | TABLET | 1 | 23 | |
| 50844-375-45 | Anti-diarrheal | 6 in 1 BLISTER PACK | TABLET | 6 | 23 | |
| 50844-375-95 | Anti-diarrheal | 6 in 1 BLISTER PACK | TABLET | 6 | 23 | |
| 50844-375-95 | Anti-diarrheal | 2 in 1 CARTON | TABLET | 2 | 23 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| LOPERAMIDE HYDROCHLORIDE | ACTIVE INGREDIENT | 77TI35393C | 6 | |
| LOPERAMIDE | ACTIVE MOIETY | 6X9OC3H4II | 6 | |
| CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 6 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | 6 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 6 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 6 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 6 |
Products#
- Anti-diarrheal
- Loperamide HCl
- LOPERAMIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50844-375 | 50844-375-45, 50844-375-02, 50844-375-95, 50844-375-08 |
Ingredients#
Complete SPL Sections#
Active ingredient (in each caplet)
Loperamide HCl 2 mg
Purpose
Anti-diarrheal
Use
controls symptoms of diarrhea, including Travelers’ Diarrhea
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
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
Other information
each caplet contains: calcium 15 mg TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store between 20º-25ºC (68º-77ºF) see end flap for expiration date and lot number
Inactive ingredients
corn starch, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide
Questions or comments?
Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday
Principal Display Panel
QUALITY + PLUS NDC 50844-375-45 *Compare to active ingredient in Imodium ® A-D ANTI- DIARRHEAL Loperamide HCl Tablets, 2 mg ANTI-DIARRHEAL Controls the symptoms of diarrhea 24 Caplets ACTUAL SIZE TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING *This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Imodium® A-D. 50844 REV0325B37545 Distributed by LNK INTERNATIONAL, INC. 60 Arkay Drive Hauppauge, NY 11788 USA 1. To open, tear 2. Use ✄ to cut at perforations and through plastic remove a section. for caplet. Quality Plus 44-375