Loperamide Hydrochloride

Manufacturer
Preferred Pharmaceuticals, Inc.
Effective date
2021-07-12
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 22:40:57

Label at a glance#

ProductLoperamide Hydrochloride
Active ingredientLOPERAMIDE HYDROCHLORIDE
Label structure9 sections

Indications and uses

• controls the symptoms of diarrhea, including Traveler's Diarrhea

Dosage and administration

• drink plenty of clear fluid to help prevent dehydration caused by diarrhea • find right dose on chart. If possible, use weight to dose; otherwise use age. • Use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device. • TSP = teaspoonful = milliliter adults and children 12 years and older 4 teaspoonfuls (20 mL) after the first loose stool movement; 2 teaspoonf...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each 5 mL teaspoonful)

Loperamide HCl 1 mg

Purpose

OTC - PURPOSE SECTION

Anti-diarrheal

Uses

INDICATIONS & USAGE SECTION

  • controls the symptoms of diarrhea, including Traveler's Diarrhea

Warnings

WARNINGS SECTION

Alergy 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 your stool
  • a history of liver disease

Ask 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • drink plenty of clear fluid to help prevent dehydration caused by diarrhea
  • find right dose on chart. If possible, use weight to dose; otherwise use age.
  • Use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
  • TSP = teaspoonful = milliliter

adults and children 12 years and older

4 teaspoonfuls (20 mL) after the first loose stool movement; 2 teaspoonfuls (10 mL) after each subsequent loose stool; but no more than 8 teaspoonfuls (40 mL) a day

children 9-11 years (60-95 lbs)

2 teaspoonfuls (10 mL) after the first loose stool movement; 1 teaspoonfuls (5 mL) after each subsequent loose stool; but no more than 6 teaspoonfuls (30 mL) a day

children 6-8 years (48-59 lbs)

2teaspoonfuls (10 mL) after the first loose stool movement; 1 teaspoonfuls (5 mL) after each subsequent loose stool; but no more than 4 teaspoonfuls (20 mL) a day

children 2-5 years (34 to 47 lbs)

ask a doctor

children under 2 years (up to 33 lbs)

do not use

Other information

SPL UNCLASSIFIED SECTION

  • Each 20 mL contains: sodium 3.2 mg
  • avoid excess heat
  • store at room temperature, 15° - 30°C (59° - 86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol (0.5%), benzoic acid, cherry flavor, glycerin, mint flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose. Citric acid may be used to adjust pH

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-262-9010

Mon. - Thurs. 9:00 am - 4:30 pm EST,

Fri. 9:00 am - 2:30 pm EST

Serious side effects associated with use of this product may be reported to this number.

Manufactured by:

Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701

Rev. 618:07 05/18
Relabeled By: Preferred Pharmaceuticals Inc.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Loperamide Hydrochloride Oral Solution 1mg/5ml
Loperamide Hydrochloride Oral Solution 1mg/5ml

Rx Choice

NDC 68788-9773

See New Warnings and Directions

Loperamide Hydrochloride Oral Solution

1 mg/5 mL

Anti-Diarrheal

Controls the Symptoms of Diarrhea, including Traveler’s Diarrheal

Each teaspoonful (5 mL) contains: Loperamide Hydrochloride 1 mg

Contains Alcohol 0.5%

Convenient dosage cup enclosed.

4 fl oz (118 mL)

Cherry Mint Flavor

HI-TECH PHARMACAL CO., INC.

Amityville, NY 11701

Relabeled By: Preferred Pharmaceuticals Inc.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-618-04ML - Milliliter50383-6188b63b39a-50bc-4955-a19f-2bf658aab63812012-07-24
50383-618-05ML - Milliliter50383-618cebec501-71fb-4138-b911-b4abaea5d47912013-10-17
50383-618-06ML - Milliliter50383-6184aff43b9-f08c-42f0-891d-7d579728476b12013-08-02
50383-618-10ML - Milliliter50383-61887fa7eba-05a0-4c90-b62a-deeca64cc69a12013-10-17
50383-618-11ML - Milliliter50383-618fdcbc23c-0d0d-4c51-9133-220296523bcb12013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393C2
LOPERAMIDEACTIVE MOIETY6X9OC3H4II2
ALCOHOLINACTIVE INGREDIENT3K9958V90M2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL2
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIM2
CHERRYINACTIVE INGREDIENTBUC5I9595W2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
MINTINACTIVE INGREDIENTFV98Z8GITP2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V32
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU2
SORBITOLINACTIVE INGREDIENT506T60A25R2
SUCROSEINACTIVE INGREDIENTC151H8M5542
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68788-977368788-9773-1
50383-618

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 8 · 428 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / PERINEURAL0.02 %w/vExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / ORAL3900 mgExact identifier — unii candidate
61 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION/ DROPS / OPHTHALMIC0.25 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRASYNOVIAL45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TROCHE / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCREAM / TOPICAL36.8 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / TOPICAL0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SUSPENSION / ORAL48209 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS9.4 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS2000 mgExact identifier — unii candidate
48 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE / ORAL1072 mgExact identifier — unii candidate
81 equally ranked IID candidates
SUCROSESUCROSEC151H8M554GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL18790 mgExact identifier — unii candidate
48 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / VAGINAL1225 mgExact identifier — unii candidate
81 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TROCHE / BUCCALNAExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, DELAYED RELEASE / ORAL295.33 mgExact identifier — unii candidate
48 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUFILM, SOLUBLE / BUCCAL3 mgExact identifier — unii candidate
35 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / RECTAL1214 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, DELAYED RELEASE / ORAL1.7 mgExact identifier — unii candidate
81 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMAEROSOL, FOAM / VAGINAL0.1 %w/wExact identifier — unii candidate
23 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRAVENOUS1276 mgExact identifier — unii candidate
44 equally ranked IID candidates
SUCROSESUCROSEC151H8M554WAFER / ORAL155.2 mgExact identifier — unii candidate
48 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSYRUP / ORAL20 mgExact identifier — unii candidate
23 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, FOR SUSPENSION / ORAL120 mgExact identifier — unii candidate
35 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCAPSULE / ORAL1111 mgExact identifier — unii candidate
44 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3ELIXIR / ORAL9306 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY, METERED / NASAL240 mgExact identifier — unii candidate
81 equally ranked IID candidates
SUCROSESUCROSEC151H8M554LOZENGE / TRANSMUCOSAL1255 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / DENTAL0.08 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
SORBITOLSORBITOL506T60A25REMULSION / TOPICAL7 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / SUBCUTANEOUS1.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUINJECTION / INTRAVENOUS864 mgExact identifier — unii candidate
35 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION / INTRAMUSCULAR7459 mgExact identifier — unii candidate
81 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SUSPENSION, EXTENDED RELEASE / ORAL5400 mgExact identifier — unii candidate
48 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / TOPICAL1800 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CLOTH / TOPICAL0.03 mg/mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPASTE / DENTAL14.6 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, ORALLY DISINTEGRATING / SUBLINGUALADJ PHExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSPRAY / NASAL5 mgExact identifier — unii candidate
61 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE / ORAL3568 mgExact identifier — unii candidate
48 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, DELAYED RELEASE / ORAL36 mgExact identifier — unii candidate
81 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, EXTENDED RELEASE / ORAL428 mgExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / VAGINAL6.4 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074352-001LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-17

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.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-17c2088c7a36db…
2026-09-14 22:38:342026-08A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-1784e616aacf4f…
2026-08-18 06:07:402026-07A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-173f01610625f2…
2019-09-15 20:21 UTC2019-09A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-173a93d1ddd44b…

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5135485e-ed86-455e-bc4f-a259760f6fcdad232149-329c-4f3d-b1c9-b34975a428fb2023-01-16WarningsExact identifier
spl set id: ad232149-329c-4f3d-b1c9-b34975a428fb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.