Indications and uses
controls symptoms of diarrhea, including Travelers’ Diarrhea
controls symptoms of diarrhea, including Travelers’ Diarrhea
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. only use attached measuring cup to dose product adults and children 12 years and over 4 teaspoonfuls (1 dosage cup) after the first loose stool; 2 teaspoonfuls (1/2 dosage cup) after each subsequent loose stool; but no more than 8 teaspoonfuls in 24 hours childre...
do not use if carton is opened or if printed plastic neckband is broken or missing store between 20°-25°C (68°-77°F) see bottom panel for lot number and expiration date
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
if you have bloody or black stool
taking antibiotics
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away.
| adults and children 12 years and over | 4 teaspoonfuls (1 dosage cup) after the first loose stool; 2 teaspoonfuls (1/2 dosage cup) after each subsequent loose stool; but no more than 8 teaspoonfuls in 24 hours |
| children 9-11 years (60-95 lbs) | 2 teaspoonfuls (1/2 dosage cup) after the first loose stool; 1 teaspoonful (1/4 dosage cup) after each subsequent loose stool; but no more than 6 teaspoonfuls in 24 hours |
| children 6-8 years (48-59 lbs) | 2 teaspoonfuls (1/2 dosage cup) after the first loose stool; 1 teaspoonful (1/4 dosage cup) after each subsequent loose stool; but no more than 4 teaspoonfuls in 24 hours |
| children under 6 years (up to 47 lbs) | ask a doctor |
alcohol (0.5%), benzoic acid, citric acid, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucrose
1-800-719-9260
| Class | Version | Type | Effective |
|---|---|---|---|
| LOPERAMIDE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 10f838ef-a72b-645d-80f8-e2255205c3b1 | Product name | 6 | 20240805 |
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-978-04 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4ca1-48b1-e053-8cdaa90a720a | Rite Aid Corporation Anti-Diarrheal Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-978-04 | Anti Diarrheal | 120 mL in 1 BOTTLE | SOLUTION | 120 | 1 | |
| 21695-978-04 | Anti Diarrheal | 1 in 1 CARTON | SOLUTION | 1 | 1 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| LOPERAMIDE HYDROCHLORIDE | ACTIVE INGREDIENT | 77TI35393C | 1 | |
| LOPERAMIDE | ACTIVE MOIETY | 6X9OC3H4II | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 21695-978 | 21695-978-04 |
| 0113-0377 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| LOPERAMIDE HYDROCHLORIDE | 77TI35393C | ACTIB |
| ALCOHOL | 3K9958V90M | IACT |
| BENZOIC ACID | 8SKN0B0MIM | IACT |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SORBITOL | 506T60A25R | IACT |
| SUCROSE | C151H8M554 | IACT |
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 |
|---|---|---|---|---|---|---|---|
| A073243-001 | LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION / ORAL | 1992-01-21 |
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 | A073243-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION / ORAL | 1992-01-21 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A073243-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION / ORAL | 1992-01-21 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A073243-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION / ORAL | 1992-01-21 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A073243-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION / ORAL | 1992-01-21 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A073243-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION / ORAL | 1992-01-21 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A073243-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION / ORAL | 1992-01-21 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A073243-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION / ORAL | 1992-01-21 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A073243-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION / ORAL | 1992-01-21 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A073243-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION / ORAL | 1992-01-21 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A073243-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION / ORAL | 1992-01-21 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A073243-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION / ORAL | 1992-01-21 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A073243-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION / ORAL | 1992-01-21 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A073243-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION / ORAL | 1992-01-21 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A073243-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION / ORAL | 1992-01-21 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A073243-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION / ORAL | 1992-01-21 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A073243-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION / ORAL | 1992-01-21 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A073243-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION / ORAL | 1992-01-21 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A073243-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION / ORAL | 1992-01-21 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A073243-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION / ORAL | 1992-01-21 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A073243-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION / ORAL | 1992-01-21 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A073243-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION / ORAL | 1992-01-21 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A073243-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION / ORAL | 1992-01-21 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A073243-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION / ORAL | 1992-01-21 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A073243-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION / ORAL | 1992-01-21 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A073243-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION / ORAL | 1992-01-21 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A073243-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION / ORAL | 1992-01-21 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A073243-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION / ORAL | 1992-01-21 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A073243-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION / ORAL | 1992-01-21 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A073243-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION / ORAL | 1992-01-21 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A073243-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION / ORAL | 1992-01-21 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A073243-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION / ORAL | 1992-01-21 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A073243-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION / ORAL | 1992-01-21 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A073243-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION / ORAL | 1992-01-21 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A073243-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION / ORAL | 1992-01-21 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A073243-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION / ORAL | 1992-01-21 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A073243-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION / ORAL | 1992-01-21 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A073243-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION / ORAL | 1992-01-21 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A073243-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION / ORAL | 1992-01-21 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A073243-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION / ORAL | 1992-01-21 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A073243-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION / ORAL | 1992-01-21 | 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 |
|---|---|---|---|---|---|---|
| 4339d964-1997-4c0e-973e-aa69b123b33d | 4339d964-1997-4c0e-973e-aa69b123b33d | 2011-09-13 | Warnings | 4339d964-1997-4c0e-973e-aa69b123b33d 4339d964-1997-4c0e-973e-aa69b123b33d |
Adverse event summaries are temporarily unavailable. Other product information remains available.