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equate diarrhea control

Wal-Mart Diarrhea Control Drug Facts

Approved
Approval ID

53283496-4e65-40ea-8dfb-851ea2c0cc15

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 19, 2025

Manufacturers
FDA

Wal-Mart Stores Inc

DUNS: 051957769

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 Code49035-695
Application NumberANDA091292
Product Classification
M
Marketing Category
C73584
G
Generic Name
Loperamide HCl
Product Specifications
Route of AdministrationORAL
Effective DateJune 19, 2025
FDA Product Classification

INGREDIENTS (15)

LOPERAMIDE HYDROCHLORIDEActive
Quantity: 1 mg in 7.5 mL
Code: 77TI35393C
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/19/2025

Package/Label Principal Display Panel

SEE NEW WARNING AND DIRECTIONS

equate™

Compare to Imodium® A-D active ingredient

DIARRHEA CONTROL

Loperamide Hydrochloride Oral Solution, 1mg per 7.5 mL

Anti-Diarrheal

FOR AGES 6 YEARS AND UP

Controls the Symptoms of Diarrhea

Anti-Diarrheal Oral Solution

Mint Flavor

4 FL OZ (118mL)

![758-2e-diarrhea-control.jpg](/dailymed/image.cfm?name=758-2e-diarrhea- control.jpg&id=882862)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 3/11/2020

Use

controls symptoms of diarrhea, including Travelers’ Diarrhea

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 3/11/2020

Active ingredient (in each 7.5 mL)

Loperamide HCl 1 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 3/11/2020

Purpose

Anti-diarrheal

WARNINGS SECTION

LOINC: 34071-1Updated: 3/11/2020

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. (1-800-222-1222)

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 3/11/2020

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.

shake well before using

use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

mL = milliliter  

adults and children 12 years and over

30 mL after the first loose stool; 15 mL after each subsequent loose stool; but no more than 60 mL in 24 hours

children 9-11 years

(60-95 lbs)

15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hours

children 6-8 years (48-59 lbs)

15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL 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: 6/19/2025

Other information

**each 30 mL contains:** sodium 15 mg

store between 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 3/11/2020

Inactive ingredients

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 6/19/2025

Questions or comments?

1-888-287-1915

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equate diarrhea control - FDA Drug Approval Details