Indications and uses
controls symptoms of diarrhea, including Travelers' Diarrhea
381
- Manufacturer
- Redpharm Drug
- Effective date
- 2026-08-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- daily-update
- Hydrated at
- 2026-08-20 01:01:25
Label at a glance#
ProductAnti-Diarrheal
Active ingredientLOPERAMIDE HYDROCHLORIDE
Label structure8 sections
Dosage and administration
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...
Storage and handling
each caplet contains: calcium 15 mg TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 20⁰C-25⁰C (68⁰F-77⁰F) see end flap for expiration date and lot number
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient(in each caplet)
Loperamide HCI 2 mg
Purpose
Anti-diarrheal
Uses
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 HCI
Heart alert:Taking more than directed can cause serious heart problems or death.
Do not useif you have bloody or black stool
Ask a doctor before use if you have
- a fever
- mucus present in your stool
- a history of liver disease
- a history of abnormal heart rhythm
Ask a doctor or pharmacist before use if you aretaking a prescription drug. Loperamide may interact with certain
prescription drugs.
When using this producttiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.
Stop use and ask a doctor if
- diarrhea lasts for more than 2 days
- symptoms get worse
- 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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.In case of overdose, get medical
help or contact a Poison Control Center right away.
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 (34-47 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 at 20⁰C-25⁰C (68⁰F-77⁰F)
- 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 1-800-540-3765
package Label
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57896-381-12 | EA - Each | 57896-381 | b8e1e77a-a057-4cdc-aabe-0c08ef7a3a35 | 1 | 2018-04-19 |
| 57896-381-13 | EA - Each | 57896-381 | 6de128ee-ca49-40ab-bf6f-0099f7afc3ea | 1 | 2022-03-09 |
| 57896-381-24 | EA - Each | 57896-381 | 564ffe4d-6390-4563-b3ab-22b82d71dbdf | 1 | 2013-06-04 |
| 57896-381-25 | EA - Each | 57896-381 | caeb2e78-e036-4961-bb90-c907fd5ef8d0 | 1 | 2022-03-09 |
| 57896-381-96 | EA - Each | 57896-381 | 25449e42-7e92-49f5-b5db-ac40c01a3898 | 1 | 2017-03-06 |
Products#
Every source-derived product name is available through these pages.
- Anti-Diarrheal
- Loperamide HCl
- LOPERAMIDE HYDROCHLORIDE
- LOPERAMIDE
- STARCH, CORN
- D&C YELLOW NO. 10
- FD&C BLUE NO. 1
- MAGNESIUM STEARATE
- SILICON DIOXIDE
- CELLULOSE, MICROCRYSTALLINE
- DIBASIC CALCIUM PHOSPHATE DIHYDRATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 67296-2314 | 67296-2314-2 |
| 57896-381 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| LOPERAMIDE HYDROCHLORIDE | 77TI35393C | ACTIB |
| 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 |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| DIBASIC CALCIUM PHOSPHATE DIHYDRATE | O7TSZ97GEP | IACT |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| 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 Orange Book product history#
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 cross-check#
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 |
|---|---|---|---|---|---|---|
| Anti-Diarrheal | LOPERAMIDE HCL | Redpharm Drug | 594b9c93-488a-0df0-e063-6394a90a2e99 | 2026-08-18 | Warnings | 67296-2314-2 67296-2314 67296231402 594b9c99-84bd-8f41-e063-6294a90aab37 594b9c93-488a-0df0-e063-6394a90a2e99 |
| Anti-Diarrheal | LOPERAMIDE HCL | Geri-Care Pharmaceutical Corp | 0ecca2cd-c971-47b2-a2ac-ae7842dd4264 | 2025-06-11 | Warnings | 57896-381 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.