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...
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store between 20°-25°C (68°-77°F) see end flap for expiration date and lot number
Loperamide HCI 2 mg
Anti-diarrheal
controls symptoms of diarrhea, including Travelers' Diarrhea
Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCI
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
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.
Stop use and ask a doctor if
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 overdose, get medical
help or contact a Poison Control Center 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 2-5 years (34-47 lbs) | ask a doctor |
| children under 2 years(up to 33 lbs) | do not use |
corn starch, D&C yellow #10 lake, dibasic calcium phosphate
dihydrate, FD&C blue #1 lake, magnesium stearate, microcrystalline cellulose, silicon dioxide
Questions or comments? call 1-800-540-3765
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 80136-381 | 80136-381-24 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DIBASIC CALCIUM PHOSPHATE DIHYDRATE | O7TSZ97GEP | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | 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 |
|---|---|---|---|---|---|---|
| 27fe47d5-003e-b29a-e063-6394a90ac85f | ad3df574-a086-5c3d-e053-2995a90a2683 | 2024-11-28 | Warnings | ad3df574-a086-5c3d-e053-2995a90a2683 |
Adverse event summaries are temporarily unavailable. Other product information remains available.