Equaline 44-375

Manufacturer
United Natural Foods, Inc. dba UNFI | LNK International, Inc.
Effective date
2026-05-18
Label type
HUMAN OTC DRUG LABEL
Version
24
Source
full-release
Hydrated at
2026-06-01 01:57:59

Label at a glance#

ProductAnti-Diarrheal
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. 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 between 20°-25°C (68°-77°F) see end flap for expiration date and lot number

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Loperamide HCl 2 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
Heart alert: Taking more than directed can cause serious heart problems or death

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
  • a history of abnormal heart rhythm

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking a prescription drug. Loperamide may interact with certain prescription drugs.

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.

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.
adults and children 12 years and over2 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 to 47 lbs)ask a doctor
children under 2 years (up to 33 lbs)do not use

Other information

STORAGE AND HANDLING SECTION

  • each caplet contains: calcium 15 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store between 20°-25°C (68°-77°F)
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

Call 1-855-423-2630 8:30 AM-6:00 PM ET, Monday-Friday

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EQUALINE®

compare to
Imodium® A-D
active ingredient*

NDC 41163-375-02

anti-diarrheal
loperamide HCl tablets, 2 mg
(anti-diarrheal)

controls the
symptoms of diarrhea

12 caplets

actual size

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

1. To open, tear
at perforations and
remove a section.

2. Use ✄ to cut
through plastic
for caplet.

*This product is not manufactured or distributed by Kenvue Inc.,
owner of the registered trademark Imodium® A-D.
50844       REV0325K37502

DISTRIBUTED BY UNFI
PROVIDENCE, RI 02903 USA
855-423-2630

100% Quality
GUARANTEED

Equaline 44-375
Equaline 44-375

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
978010loperamide HCl 2 MG Oral TabletPSN24
978010loperamide hydrochloride 2 MG Oral TabletSCD24

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130041163233485GTIN-13: 0041163233485
EAN-13: 0041163233485
GTIN-12: 041163233485
UPC-A: 041163233485
GTIN storage (14 digits): 00041163233485
equaline-44-375-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
10f838ef-a72b-645d-80f8-e2255205c3b1Product name620240805

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-375-02Anti-Diarrheal2 in 1 CARTONTABLET224
41163-375-02Anti-Diarrheal6 in 1 BLISTER PACKTABLET624
41163-375-08Anti-Diarrheal4 in 1 CARTONTABLET424
41163-375-08Anti-Diarrheal6 in 1 BLISTER PACKTABLET624
41163-375-44Anti-Diarrheal3 in 1 CARTONTABLET324
41163-375-44Anti-Diarrheal6 in 1 BLISTER PACKTABLET624

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41163-375-02EA - Each41163-375060613ec-67d7-4e2a-9994-f13fc8b9626612016-10-06
41163-375-08EA - Each41163-375ec872628-1d13-46b7-bc90-547ba661a52312016-06-14
41163-375-22EA - Each41163-375d26cbdec-e730-459c-abe8-8245827f460812016-12-07
41163-375-44EA - Each41163-375fb41a48c-ad00-4a54-a87d-dbe8aaa4855612016-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393C5
LOPERAMIDEACTIVE MOIETY6X9OC3H4II5
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEP5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3G5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I305

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41163-37541163-375-02, 41163-375-08, 41163-375-44

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML · Source PDF

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 1 · 20 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET / ORAL2442 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET / ORAL80 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / ORAL27.53 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET / ORAL80 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET / ORAL2442 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET / ORAL80 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET / ORAL80 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET / ORAL2442 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / ORAL27.53 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET / ORAL2442 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / ORAL27.53 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / ORAL27.53 mgExact identifier — unii+route+dosage form
4 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 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
A076497-001LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10

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.

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 22:38:342026-08A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-1084e616aacf4f…
2026-08-18 06:07:402026-07A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-103f01610625f2…
2019-09-15 20:21 UTC2019-09A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10b00525d2431f…
2019-07-19 19:46 UTC2019-07A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10f41ea6bd6efb…

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
Anti-DiarrhealLOPERAMIDE HCLUnited Natural Foods, Inc. dba UNFIf16e07f3-0efb-4451-adbb-e427f9abc7ae2026-05-18WarningsExact identifier
ndc (package): 41163-375-02
ndc (package): 41163-375-44
ndc (package): 41163-375-08
ndc (product): 41163-375
ndc11 (package): 41163037502
ndc11 (package): 41163037544
ndc11 (package): 41163037508
spl id: 6954acb7-91c1-491a-85a6-964d4a8d4077
spl set id: f16e07f3-0efb-4451-adbb-e427f9abc7ae

Reported adverse events (FAERS/openFDA)#

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