MedPath

Anti-Diarrheal

Kroger 44-375

Approved
Approval ID

49049c95-b19c-4ff0-a1bd-bc7b4193e875

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 12, 2025

Manufacturers
FDA

Kroger Company

DUNS: 006999528

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Loperamide HCl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code30142-775
Application NumberANDA076497
Product Classification
M
Marketing Category
C73584
G
Generic Name
Loperamide HCl
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 12, 2025
FDA Product Classification

INGREDIENTS (8)

LOPERAMIDE HYDROCHLORIDEActive
Quantity: 2 mg in 1 1
Code: 77TI35393C
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JM
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/12/2025

Principal Display Panel

NDC 30142-775-08

Kroger****®************
********health

COMPARE TOTHEACTIVE
** INGREDIENT IN IMODIUM****®**** A-D***

Anti-Diarrheal

Loperamide Hydrochloride Tablets, 2 mg
****Anti-Diarrheal

CONTROLS THE SYMPTOMS
** OF DIARRHEA**

ACTUAL SIZE

24 CAPLETS

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.

*IMODIUM® is a registered trademark of Kenvue Inc. Kenvue Inc. is not
affiliated with The Kroger Co. or this product.
50844 REV0325A37508

PROUDLY DISTRIBUTED
** BY THE KROGER CO.**
** CINCINNATI, OHIO 45202**
** ‡OUR PHARMACIST RECOMMENDED**

Quality Guaranteed
** Kroger.com/guarantee**
** 800-632-6900**

FOR MORE PRODUCT INFORMATION, SCAN UPC
****USING YOUR KROGER APP OR CALL 800-632-6900

Kroger 44-375

Kroger 44-375


INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/12/2025

Use

controls symptoms of diarrhea, including Travelers’ Diarrhea

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/12/2025

Active ingredient (in each caplet)

Loperamide HCl 2 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/12/2025

Purpose

Anti-diarrheal

WARNINGS SECTION

LOINC: 34071-1Updated: 9/12/2025

Warnings

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

if you have bloody or black stool

Ask a doctor before use if you have

  • 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

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

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 for 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.

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/12/2025

Directions

*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 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

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 9/12/2025

Other information

***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 INGREDIENT SECTION

LOINC: 51727-6Updated: 9/12/2025

Inactive ingredients

corn starch, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/12/2025

Questions or comments?

Call 1-800-632-6900

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Anti-Diarrheal - FDA Drug Approval Details