Amerisource Bergen Loperamide Hydrochloride Oral Suspension Drug Facts

Manufacturer
ATLANTIC BIOLOGICALS CORP.
Effective date
2021-01-25
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:37:15

Label at a glance#

Productgood neighbor pharmacy Loperamide hydrochloride
Active ingredientLOPERAMIDE HYDROCHLORIDE
Label structure9 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. • shake well before using • only use attached measuring cup to dose product adults and children 12 years and over 30 mL (6 tsp) after the first loose stool; 15 mL (3 tsp) after each subsequent loose stool; but no more than 60 mL (12 tsp) in 24 hours children ...

Storage and handling

• each 30 mL (6 tsp) contains: sodium 15 mg • store between 20-25°C (68-77°F) • see side panel for lot number and expiration date

Label contents#

Full prescribing information#

Active ingredient (in each 7.5 mL)

OTC - ACTIVE INGREDIENT SECTION

Loperamide HCl 1 mg

Purpose

OTC - PURPOSE SECTION

Anti-diarrheal

Use

INDICATIONS & USAGE SECTION

controls symptoms of diarrhea, including Travelers’ Diarrhea

Warnings

WARNINGS SECTION

Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCl

Do not use

OTC - DO NOT USE SECTION

if you have bloody or black stool

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • fever
  • mucus in the stool
  • a history of liver disease

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking antibiotics

When using this product

OTC - WHEN USING SECTION

  • tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • symptoms get worse
  • diarrhea lasts for more than 2 days
  • you get abdominal swelling or bulging.

These may be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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
  • only use attached measuring cup to dose product

adults and children

12 years and over

30 mL (6 tsp) after the first loose stool; 15 mL (3 tsp) after each subsequent loose stool; but no more than 60 mL (12 tsp) in 24 hours

children 9-11 years

(60-95 lbs)

15 mL (3 tsp) after the first loose stool; 7.5 mL (1 1/2 tsp) after each subsequent loose stool; but no more than 45 mL (9 tsp) in 24 hours

children 6-8 years

(48-59 lbs)

15 mL (3 tsp) after the first loose stool; 7.5 mL (1 1/2 tsp) after each subsequent loose stool; but no more than 30 mL (6 tsp) in 24 hours

children under

6 years

(up to 47 lbs)

ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each 30 mL (6 tsp) contains: sodium 15 mg
  • store between 20-25°C (68-77°F)
  • see side panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

DISTRIBUTED BY: ATLANTIC BIOLOGICALS CORP.20101 N.E 16TH PLACEMIAMI,FL 33179

OTC - QUESTIONS SECTION

1-800-719-9260

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Imodium® A-D active ingredient

Loperamide Hydrochloride Oral Suspension

anti-diarrheal

Controls the Symptoms of Diarrhea

mint flavor

NDC 17856-0111-06

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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1250685loperamide HCl 1 MG in 7.5 mL Oral SuspensionPSN4
1250685loperamide hydrochloride 0.133 MG/ML Oral SuspensionSCD4
1250685loperamide HCl 1 MG per 7.5 ML Oral SolutionSY4
1250685loperamide hydrochloride 1 MG per 7.5 ML Oral SuspensionSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LOPERAMIDE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
10f838ef-a72b-645d-80f8-e2255205c3b1Product name620240805
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0111-2good neighbor pharmacy Loperamide hydrochloride10 mL in 1 CUP, UNIT-DOSESUSPENSION104
17856-0111-2good neighbor pharmacy Loperamide hydrochloride72 in 1 BOX, UNIT-DOSESUSPENSION724
17856-0111-3good neighbor pharmacy Loperamide hydrochloride72 in 1 BOX, UNIT-DOSESUSPENSION724
17856-0111-3good neighbor pharmacy Loperamide hydrochloride5 mL in 1 CUP, UNIT-DOSESUSPENSION54
17856-0111-4good neighbor pharmacy Loperamide hydrochloride15 mL in 1 CUP, UNIT-DOSESUSPENSION154
17856-0111-4good neighbor pharmacy Loperamide hydrochloride72 in 1 BOX, UNIT-DOSESUSPENSION724
17856-0111-5good neighbor pharmacy Loperamide hydrochloride72 in 1 BOX, UNIT-DOSESUSPENSION724
17856-0111-5good neighbor pharmacy Loperamide hydrochloride7.5 mL in 1 CUP, UNIT-DOSESUSPENSION7.54
17856-0111-6good neighbor pharmacy Loperamide hydrochloride15 mL in 1 CUP, UNIT-DOSESUSPENSION154
17856-0111-6good neighbor pharmacy Loperamide hydrochloride50 in 1 BOX, UNIT-DOSESUSPENSION504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0111GOOD NEIGHBOR PHARMACY LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [ATLANTIC BIOLOGICALS CORP.]4Legacy NDC, 10 package rows20210126_0c9a897d-475c-425c-b2fa-5dfd68785e08.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-111-26ML - Milliliter46122-11115ed6240-9be5-4daf-a8a1-6d27e3c554d512013-02-13

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17856-011117856-0111-2, 17856-0111-3, 17856-0111-4, 17856-0111-5, 17856-0111-6
46122-111

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

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 43.

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
A091292-001LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDE1MG/7.5MLSOLUTION / ORAL2011-05-20

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSOLUTION / ORAL2011-05-2084e616aacf4f…
2026-08-18 06:07:402026-07A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSOLUTION / ORAL2011-05-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSOLUTION / ORAL2011-05-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSOLUTION / ORAL2011-05-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-203f01610625f2…
2019-09-15 20:21 UTC2019-09A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20f41ea6bd6efb…

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
ea920bbd-2ecb-4436-a9ed-d6aa27327c5c0c9a897d-475c-425c-b2fa-5dfd68785e082021-01-25WarningsExact identifier
spl id: ea920bbd-2ecb-4436-a9ed-d6aa27327c5c
spl set id: 0c9a897d-475c-425c-b2fa-5dfd68785e08

Reported adverse events (FAERS/openFDA)#

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