Anti-diarrheal

SPL v2

SPL

SPL Set ID 043b0ab4-8fba-37d1-e063-6394a90a4cd4

Route

ORAL

Published

Effective Date 2023-08-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Loperamide (2 mg)

Inactive Ingredients

Crospovidone (15 Mpa.s At 5%) D&c Yellow No. 10 Starch, Corn Powdered Cellulose Anhydrous Lactose Fd&c Blue No. 1 Hydrogenated Cottonseed Oil Croscarmellose Sodium Magnesium Stearate

Identifiers & Packaging

Pill Appearance

Imprint: 123 Shape: oval Color: green Size: 9 mm Score: 1

Marketing Status

ANDA Active Since 2022-05-06

Description

Drug Facts

Purpose

Purpose Anti-diarrheal

Medication Information

Purpose

Purpose

Anti-diarrheal

Description

Drug Facts

Use

Use

Controls symptoms of diarrhea, including Travelers’ Diarrhea

Warnings

Warnings

Directions

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 (up to 33 lbs)	do not use

Do Not Use

Do not useif you have bloody or black stool

Drug Facts

Drug Facts

Heart Alert

Heart alert:Taking more than directed can cause serious heart problems or death.

Allergy Alert

Allergy alert:Do not use if you have ever had a rash or other allergic reaction to Loperamide HCl.

Active Ingredient

Active ingredient (in each caplet)

Loperamide HCl, USP 2 mg

Other Information

Other information

store between 68-77°F (20-25°C)

Inactive Ingredients

Inactive ingredients

anhydrous lactose, croscarmellose sodium, crospovidone, D&C Yellow no. 10 aluminum lake, FD&C Blue no. 1 aluminum lake, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch

Questions Or Comments?

Questions or comments?

call toll-free 1-877-507-6516(M-F 8AM - 4:30PM CST)

When Using This Product

When using this producttiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

Anti Diarrheal 4ct, Cvp ®

Compare to the

active ingredient in

Imodium ^®A-D*

Anti-

Diarrheal

Loperamide HCl Tablets,

USP 2mg

Controls the Symptoms

of Diarrhea

[caplet image]

actual size

4 Caplets*

CVP _®

HEALTH

Ask A Doctor Or Pharmacist

Ask a doctor or pharmacist before use if you aretaking a prescription drug. Loperamide may interact with certain prescription drugs.

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. (1-800-222-1222)

Ask A Doctor Before Use If You Have

Ask a doctor before use if you have

fever
mucus in the stool
a history of liver disease
a history of abnormal heart rhythm

Anti Diarrheal 4ct, Casey's 4good Tm

Compare to the

active ingredient in

Imodium ^®A-D*

Anti-

Diarrheal

Loperamide HCI Tablets, USP 2mg

Controls the symptoms of diarrhea

[Casey's logo]

[caplet image]

actual size

4 CAPLETS**

Structured Label Content

Use

Use

Controls symptoms of diarrhea, including Travelers’ Diarrhea

Purpose

Purpose

Anti-diarrheal

Warnings

Warnings

Directions

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 (up to 33 lbs)	do not use

Do Not Use (Do not use)

Do not useif you have bloody or black stool

Drug Facts

Drug Facts

Heart Alert (Heart alert)

Heart alert:Taking more than directed can cause serious heart problems or death.

Allergy Alert (Allergy alert)

Allergy alert:Do not use if you have ever had a rash or other allergic reaction to Loperamide HCl.

Active Ingredient (Active ingredient)

Active ingredient (in each caplet)

Loperamide HCl, USP 2 mg

Other Information (Other information)

Other information

store between 68-77°F (20-25°C)

Inactive Ingredients (Inactive ingredients)

Inactive ingredients

Questions Or Comments? (Questions or comments?)

Questions or comments?

call toll-free 1-877-507-6516(M-F 8AM - 4:30PM CST)

When Using This Product (When using this product)

When using this producttiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

Anti Diarrheal 4ct, Cvp ® (Anti-Diarrheal 4ct, CVP ®)

Compare to the

active ingredient in

Imodium ^®A-D*

Anti-

Diarrheal

Loperamide HCl Tablets,

USP 2mg

Controls the Symptoms

of Diarrhea

[caplet image]

actual size

4 Caplets*

CVP _®

HEALTH

Ask A Doctor Or Pharmacist (Ask a doctor or pharmacist)

Ask a doctor or pharmacist before use if you aretaking a prescription drug. Loperamide may interact with certain prescription drugs.

Stop Use and Ask A Doctor If (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)

If pregnant or breast-feeding,ask a health professional before use.

Keep Out of Reach of Children (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. (1-800-222-1222)

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

Ask a doctor before use if you have

fever
mucus in the stool
a history of liver disease
a history of abnormal heart rhythm

Anti Diarrheal 4ct, Casey's 4good Tm (Anti-Diarrheal 4ct, Casey's 4good TM)

Compare to the

active ingredient in

Imodium ^®A-D*

Anti-

Diarrheal

Loperamide HCI Tablets, USP 2mg

Controls the symptoms of diarrhea

[Casey's logo]

[caplet image]

actual size

4 CAPLETS**

Advanced Ingredient Data

[{"name": "CROSPOVIDONE (15 MPA.S AT 5%)", "unii": "68401960MK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C YELLOW NO. 10", "unii": "35SW5USQ3G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POWDERED CELLULOSE", "unii": "SMD1X3XO9M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS LACTOSE", "unii": "3SY5LH9PMK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROGENATED COTTONSEED OIL", "unii": "Z82Y2C65EA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LOPERAMIDE", "unii": "6X9OC3H4II", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CROSPOVIDONE (15 MPA.S AT 5%)", "unii": "68401960MK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C YELLOW NO. 10", "unii": "35SW5USQ3G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POWDERED CELLULOSE", "unii": "SMD1X3XO9M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS LACTOSE", "unii": "3SY5LH9PMK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROGENATED COTTONSEED OIL", "unii": "Z82Y2C65EA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LOPERAMIDE", "unii": "6X9OC3H4II", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Use": "Use Controls symptoms of diarrhea, including Travelers’ Diarrhea", "Purpose": "Purpose Anti-diarrheal", "Warnings": "Warnings", "Directions": "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 (up to 33 lbs) do not use", "Do not use": "Do not use if you have bloody or black stool", "Drug Facts": "Drug Facts", "Heart alert": "Heart alert: Taking more than directed can cause serious heart problems or death.", "Allergy alert": "Allergy alert: Do not use if you have ever had a rash or other allergic reaction to Loperamide HCl.", "Active ingredient": "Active ingredient (in each caplet) Loperamide HCl, USP 2 mg", "Other information": "Other information store between 68-77°F (20-25°C)", "Inactive ingredients": "Inactive ingredients anhydrous lactose, croscarmellose sodium, crospovidone, D&C Yellow no. 10 aluminum lake, FD&C Blue no. 1 aluminum lake, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch", "Questions or comments?": "Questions or comments? call toll-free 1-877-507-6516 (M-F 8AM - 4:30PM CST)", "When using this product": "When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.", "Anti-Diarrheal 4ct, CVP ®": "Compare to the active ingredient in Imodium ® A-D* Anti- Diarrheal Loperamide HCl Tablets, USP 2mg Controls the Symptoms of Diarrhea [caplet image] actual size 4 Caplets* CVP ® HEALTH", "Ask a doctor or pharmacist": "Ask a doctor or pharmacist before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs.", "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. (1-800-222-1222)", "Ask a doctor before use if you have": "Ask a doctor before use if you have fever mucus in the stool a history of liver disease a history of abnormal heart rhythm", "Anti-Diarrheal 4ct, Casey's 4good TM": "Compare to the active ingredient in Imodium ® A-D* Anti- Diarrheal Loperamide HCI Tablets, USP 2mg Controls the symptoms of diarrhea [Casey's logo] [caplet image] actual size 4 CAPLETS**"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:07.600823 · Updated: 2026-03-14T23:06:27.679265