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 s...
store between 20° and 25°C (68° and 77°F)
Loperamide HCl 2 mg
Anti-diarrheal
controls symptoms of diarrhea, including Traveler's Diarrhea
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.
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
| 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 |
Corn starch, D&C yellow #10 aluminum lake, dicalcium phosphate dihydrate, FD&C blue #1 brilliant blue lake, magnesium stearate, microcrystalline cellulose, silica gel
call toll free 1-800-687-0176
Mon - Fri 8 am to 4 pm
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
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 66424-735-02 | 2021-04-29 | C162847 | 48780-1 | ba0f9c33-443d-a910-e053-dadaa90a0b85 | SDA LABORATORIES - ANTI-DIARRHEAL LOPERAMIDE HYDROCHLORIDE, 2 mg CAPLETS |
| 66424-735-96 | 2021-04-29 | C162847 | 48780-1 | ba0f9c33-443d-a910-e053-dadaa90a0b85 | SDA LABORATORIES - ANTI-DIARRHEAL LOPERAMIDE HYDROCHLORIDE, 2 mg CAPLETS |
| 66424-735-02 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-443d-a910-e053-dadaa90a0b85 | SDA LABORATORIES - ANTI-DIARRHEAL LOPERAMIDE HYDROCHLORIDE, 2 mg CAPLETS |
| 66424-735-96 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-443d-a910-e053-dadaa90a0b85 | SDA LABORATORIES - ANTI-DIARRHEAL LOPERAMIDE HYDROCHLORIDE, 2 mg CAPLETS |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 66424-735 | 66424-735-02, 66424-735-96 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| STARCH, CORN | O8232NY3SJ | IACT |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| DIBASIC CALCIUM PHOSPHATE DIHYDRATE | O7TSZ97GEP | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| LOPERAMIDE HYDROCHLORIDE | 77TI35393C | ACTIB |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076497-001 | LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | f41ea6bd6efb… |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 0eb0909f-f09e-a1cc-e063-6394a90a1868 | e3d4f789-d41c-4965-975b-5af743d7b8e3 | 2024-01-11 | Warnings | e3d4f789-d41c-4965-975b-5af743d7b8e3 |
Adverse event summaries are temporarily unavailable. Other product information remains available.