quality choice 44-375 delisted

SPL v14

SPL

SPL Set ID 3d2d211f-546b-48fe-b47c-d4a254f952a3

Route

oral

Published

Effective Date 2025-02-03

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 2005-05-03 Until 2028-01-21

Purpose

Anti-diarrheal

Description

Loperamide HCl 2 mg

Medication Information

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.

Purpose

Anti-diarrheal

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

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

Description

Loperamide HCl 2 mg

Principal Display Panel

QC_®

Quality

Choice

NDC 63868-559-12

*Compare to the active

ingredient in IMODIUM® A-D

Anti-Diarrheal

Loperamide HCl Tablets, 2 mg

Anti-Diarrheal

Controls the Symptoms of Diarrhea

actual

size

12 Caplets

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

Kenvue Inc., owner of the registered trademark IMODIUM® A-D.

Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

1. To open, tear 2. Use ✄ to cut

at perforations and through plastic

remove a section. for caplet.

50844 REV0619B37502

Quality Choice 44-375

Use

controls symptoms of diarrhea, including Travelers’ Diarrhea

Do Not Use

if you have bloody or black stool.

Questions Or Comments?

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

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.

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

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.

Purpose

Anti-diarrheal

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

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

Principal Display Panel (Principal display panel)

QC_®

Quality

Choice

NDC 63868-559-12

*Compare to the active

ingredient in IMODIUM® A-D

Anti-Diarrheal

Loperamide HCl Tablets, 2 mg

Anti-Diarrheal

Controls the Symptoms of Diarrhea

actual

size

12 Caplets

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

Kenvue Inc., owner of the registered trademark IMODIUM® A-D.

Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

1. To open, tear 2. Use ✄ to cut

at perforations and through plastic

remove a section. for caplet.

50844 REV0619B37502

Quality Choice 44-375

Use

controls symptoms of diarrhea, including Travelers’ Diarrhea

Do Not Use (Do not use)

if you have bloody or black stool.

Questions Or Comments? (Questions or comments?)

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

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 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

[{"name": "LOPERAMIDE", "unii": "6X9OC3H4II", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C YELLOW NO. 10 ALUMINUM LAKE", "unii": "CQ3XH3DET6", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIBASIC CALCIUM PHOSPHATE DIHYDRATE", "unii": "O7TSZ97GEP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1 ALUMINUM LAKE", "unii": "J9EQA3S2JM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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": "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": "QC ® Quality Choice NDC 63868-559-12 *Compare to the active ingredient in IMODIUM® A-D Anti-Diarrheal Loperamide HCl Tablets, 2 mg Anti-Diarrheal Controls the Symptoms of Diarrhea actual size 12 Caplets 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 Kenvue Inc., owner of the registered trademark IMODIUM® A-D. Distributed by CDMA, Inc. Novi, MI 48375 www.qualitychoice.com Questions: 800-935-2362 1. To open, tear 2. Use ✄ to cut at perforations and through plastic remove a section. for caplet. 50844 REV0619B37502 Quality Choice 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 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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:28.448345 · Updated: 2026-03-14T23:07:22.014703