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. shake well before using use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device. mL = milliliter adults and children 12 years and over 30 mL after the first loose stool; 15 mL after each subsequent loose st...
each 30 mL contains: sodium 15 mg store between 20-25 ° C (68-77 ° F)
Loperamide HCl 1 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 HCl
Heart alert:Taking more than directed can cause serious heart problems or death
if you have bloody or black stool
taking a prescription drug. Loperamide may interact with certain prescription drugs.
tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
adults and children 12 years and over | 30 mL after the first loose stool; 15 mL after each subsequent loose stool; but no more than 60 mL in 24 hours |
children 9-11 years (60-95 lbs) | 15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hours |
children 6-8 years (48-59 lbs) | 15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL 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 |
anhydrous citric acid, carboxymethylcellulose sodium, D&C yellow no. 10, FD&C blue no. 1, glycerin, microcrystalline cellulose, natural and artificial mint flavor, propylene glycol, purified water, simethicone, sodium benzoate, sucralose, titanium dioxide, xanthan gum
1-800-509-7592
Questions or comments?
DISTRIBUTED BY:
ATLANTIC BILOGICALS CORP.
20101 N.E 16TH PLACE
MIAMI, FL 33179
Compared to the active ingredient in Imodium® A-D
17856-6836-01 Loperamide Hydrochloride Oral Solution, 1 mg per 7.5 mL
17856-6836-02 Loperamide Hydrochloride Oral Solution, 2 mg per 15 mL
17856-6836-05 Loperamide Hydrochloride Oral Solution, 1.3 mg per 10 mL
Anti-Diarrheal
Controls the symptoms of diarrhea
Mint Flavor - Anti-Diarrheal Oral Solution
SEE NEW WARNING AND DIRECTIONS
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | Data Matrix | (01)00317856683616(21)39960801(10)399608(17)250505 | GTIN-14: 00317856683616 GTIN-12: 317856683616 UPC-A: 317856683616 EAN-13: 0317856683616 GTIN storage (14 digits): 00317856683616 | 17856-6836-01 Case Label.jpg |
| Barcode | Data Matrix | (01)00317856683623(21)39667001(10)396670(17)241109 | GTIN-14: 00317856683623 GTIN-12: 317856683623 UPC-A: 317856683623 EAN-13: 0317856683623 GTIN storage (14 digits): 00317856683623 | 17856-6836-02 Case Label.jpg |
| Barcode | Data Matrix | (01)00317856683654(17)270420(10)027988(21)0279881000 | GTIN-14: 00317856683654 GTIN-12: 317856683654 UPC-A: 317856683654 EAN-13: 0317856683654 GTIN storage (14 digits): 00317856683654 | 17856-6836-05 Rev.1 Case Label.jpg |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 10f838ef-a72b-645d-80f8-e2255205c3b1 | Product name | 6 | 20240805 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 17856-6836-1 | ML - Milliliter | 17856-6836 | af7d0ad5-9b7d-4d75-ba3c-a88a12f26f30 | 1 | 2022-11-07 |
| 0904-6836-20 | ML - Milliliter | 0904-6836 | fd8396f5-01b5-48dd-8016-7dc263673e7d | 1 | 2019-07-02 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 17856-6836 | 17856-6836-3, 17856-6836-1, 17856-6836-4, 17856-6836-2, 17856-6836-5 |
| 0904-6836 |
Every source-derived ingredient row is available through these pages.
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 5 | 2026-10-15 | daily-update | 2026-10-22 02:01:56 |
| 4 | 2025-05-12 | full-release | 2026-06-01 01:00:52 |
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 |
|---|---|---|---|---|---|---|---|
| A091292-001 | LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SOLUTION / ORAL | 2011-05-20 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A091292-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SOLUTION / ORAL | 2011-05-20 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091292-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SOLUTION / ORAL | 2011-05-20 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091292-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SOLUTION / ORAL | 2011-05-20 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091292-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SOLUTION / ORAL | 2011-05-20 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091292-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SOLUTION / ORAL | 2011-05-20 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091292-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SUSPENSION / ORAL | 2011-05-20 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091292-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SUSPENSION / ORAL | 2011-05-20 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091292-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SUSPENSION / ORAL | 2011-05-20 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091292-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SUSPENSION / ORAL | 2011-05-20 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091292-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SUSPENSION / ORAL | 2011-05-20 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091292-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SUSPENSION / ORAL | 2011-05-20 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091292-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SUSPENSION / ORAL | 2011-05-20 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A091292-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SUSPENSION / ORAL | 2011-05-20 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091292-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SUSPENSION / ORAL | 2011-05-20 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091292-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SUSPENSION / ORAL | 2011-05-20 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091292-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SUSPENSION / ORAL | 2011-05-20 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A091292-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SUSPENSION / ORAL | 2011-05-20 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091292-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SUSPENSION / ORAL | 2011-05-20 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A091292-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SUSPENSION / ORAL | 2011-05-20 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A091292-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SUSPENSION / ORAL | 2011-05-20 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A091292-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SUSPENSION / ORAL | 2011-05-20 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A091292-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SUSPENSION / ORAL | 2011-05-20 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A091292-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SUSPENSION / ORAL | 2011-05-20 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A091292-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SUSPENSION / ORAL | 2011-05-20 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A091292-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SUSPENSION / ORAL | 2011-05-20 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A091292-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SUSPENSION / ORAL | 2011-05-20 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A091292-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SUSPENSION / ORAL | 2011-05-20 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A091292-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SUSPENSION / ORAL | 2011-05-20 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A091292-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SUSPENSION / ORAL | 2011-05-20 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A091292-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SUSPENSION / ORAL | 2011-05-20 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A091292-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SUSPENSION / ORAL | 2011-05-20 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A091292-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SUSPENSION / ORAL | 2011-05-20 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A091292-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SUSPENSION / ORAL | 2011-05-20 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A091292-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SUSPENSION / ORAL | 2011-05-20 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A091292-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SUSPENSION / ORAL | 2011-05-20 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A091292-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SUSPENSION / ORAL | 2011-05-20 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A091292-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SUSPENSION / ORAL | 2011-05-20 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A091292-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SUSPENSION / ORAL | 2011-05-20 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A091292-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SUSPENSION / ORAL | 2011-05-20 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A091292-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SUSPENSION / ORAL | 2011-05-20 | 3a93d1ddd44b… |
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 |
|---|---|---|---|---|---|---|
| loperamide hydrochloride | LOPERAMIDE HCL | Major Pharmaceuticals | cf5dc855-f0cc-4d7e-8d15-472f7e654409 | 2026-02-13 | Warnings | 0904-6836 |
| 34f553fc-3b63-65ee-e063-6294a90a3992 | 7030f4ed-3cd1-428e-9cae-3b14933d41f5 | 2025-05-12 | Warnings | 7030f4ed-3cd1-428e-9cae-3b14933d41f5 |
Adverse event summaries are temporarily unavailable. Other product information remains available.