Premier Value 44-375-delisted

Premier Value 44-375-delisted
SPL v7
SPL
SPL Set ID 1b82f4ce-0cf5-46d1-9894-9f1271b29569
Route
ORAL
Published
Effective Date 2025-07-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loperamide (2 mg)
Inactive Ingredients
Starch, Corn D&c Yellow No. 10 Aluminum Lake Dibasic Calcium Phosphate Dihydrate Fd&c Blue No. 1 Aluminum Lake Magnesium Stearate Microcrystalline Cellulose Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;375 Shape: oval Color: green Size: 10 mm Score: 2
Marketing Status
ANDA Completed Since 2019-12-06 Until 2026-11-30
Description

Loperamide HCl 2 mg

Purpose

Anti-diarrheal

Medication Information

Purpose

Anti-diarrheal

Description

Loperamide HCl 2 mg

Use

controls symptoms of diarrhea, including Travelers’ Diarrhea

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.

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 (34-47 lbs) ask a doctor
children under 2 years (up to 33 lbs) do not use
Do Not Use

if you have bloody or black stool.

Other Information
  • 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

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?

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal Display Panel

*COMPARE TO THE ACTIVE INGREDIENT IN IMODIUM® A-D

Premier

Value®

Anti-diarrheal

Loperamide HCl Tablets, 2 mg

ANTI-DIARRHEAL

Controls the symptoms

of diarrhea

6 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

*This product is not manufactured or distributed by Johnson &

Johnson Corporation, owner of the registered trademark Imodium® A-D.

50844 ORG061937545

Distributed by:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue, Wayne, PA 19087



INDEPENDENTLY TESTED

PV

SATISFACTION GUARANTEED

If for any reason you are not satisfied with

this product, please return it to the store

where purchased for a full refund.

Premier Value 44-375

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 (1-800-222-1222) right away.

Active Ingredient (in Each Caplet)

Loperamide HCl 2 mg

Ask A Doctor Before Use If You Have
  • a 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.

Structured Label Content

Use

controls symptoms of diarrhea, including Travelers’ Diarrhea

Purpose

Anti-diarrheal

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.

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 (34-47 lbs) ask a doctor
children under 2 years (up to 33 lbs) do not use
Do Not Use (Do not use)

if you have bloody or black stool.

Other Information (Other information)
  • 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 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

Questions Or Comments? (Questions or comments?)

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal Display Panel

*COMPARE TO THE ACTIVE INGREDIENT IN IMODIUM® A-D

Premier

Value®

Anti-diarrheal

Loperamide HCl Tablets, 2 mg

ANTI-DIARRHEAL

Controls the symptoms

of diarrhea

6 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

*This product is not manufactured or distributed by Johnson &

Johnson Corporation, owner of the registered trademark Imodium® A-D.

50844 ORG061937545

Distributed by:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue, Wayne, PA 19087



INDEPENDENTLY TESTED

PV

SATISFACTION GUARANTEED

If for any reason you are not satisfied with

this product, please return it to the store

where purchased for a full refund.

Premier Value 44-375

When Using This Product, (When using this product,)

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

Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Loperamide HCl 2 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a 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 (Ask a doctor or pharmacist before use if you are)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:34.897568 · Updated: 2026-03-14T23:09:26.831955