Anti-diarrheal, Circle K

SPL v3

SPL

SPL Set ID d3aaad65-f4cd-5eb0-e053-2995a90ade84

Route

ORAL

Published

Effective Date 2021-03-26

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Loperamide (2 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

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

Marketing Status

ANDA Active Since 2021-03-26

Description

Loperamide HCl, USP 2 mg

Purpose

Anti-diarrheal

Medication Information

Purpose

Anti-diarrheal

Description

Loperamide HCl, USP 2 mg

Pdp

CONTROLS THE SYMPTOMS OF DIARRHEA

Compare to the active ingredient in

Imodium® A-D*

CIRCLE K ^™

antidiarrheal

Loperamide HCI

Tablets, USP

2 mg

[caplet image]

actual size

4 caplets**(2 per pouch)

Use

Controls symptoms of diarrhea, including Travelers’ Diarrhea

Section 50565-1

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)

Section 50566-9

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.

Section 50567-7

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

Section 50568-5

Ask a doctor or pharmacist before use if you aretaking a prescription

drug. Loperamide may interact with certain prescription drugs.

Section 50569-3

Ask a doctor before use if you have

■ fever

■ mucus in the stool

■ a history of liver disease

■ a history of abnormal heart rhythm

Section 50570-1

Do not useif you have bloody or black stool

Section 53414-9

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

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 hour

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

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.

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)

Active Ingredient (in Each Caplet)

Loperamide HCl, USP 2 mg

Structured Label Content

Pdp (PDP)

CONTROLS THE SYMPTOMS OF DIARRHEA

Compare to the active ingredient in

Imodium® A-D*

CIRCLE K ^™

antidiarrheal

Loperamide HCI

Tablets, USP

2 mg

[caplet image]

actual size

4 caplets**(2 per pouch)

Use

Controls symptoms of diarrhea, including Travelers’ Diarrhea

Section 50565-1 (50565-1)

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)

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

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

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you aretaking a prescription

drug. Loperamide may interact with certain prescription drugs.

Section 50569-3 (50569-3)

Ask a doctor before use if you have

■ fever

■ mucus in the stool

■ a history of liver disease

■ a history of abnormal heart rhythm

Section 50570-1 (50570-1)

Do not useif you have bloody or black stool

Section 53414-9 (53414-9)

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

Purpose

Anti-diarrheal

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 hour

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

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.

Other Information (Other information)

Other information

■ store between 68-77°F (20-25°C)

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)

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

Loperamide HCl, USP 2 mg

Advanced Ingredient Data

[{"name": "CROSCARMELLOSE", "unii": "029TFK992N", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C YELLOW NO. 10", "unii": "35SW5USQ3G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSPOVIDONE (15 MPA.S AT 5%)", "unii": "68401960MK", "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": "ANHYDROUS LACTOSE", "unii": "3SY5LH9PMK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POWDERED CELLULOSE", "unii": "SMD1X3XO9M", "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)

{"PDP": "CONTROLS THE SYMPTOMS OF DIARRHEA Compare to the active ingredient in Imodium® A-D* CIRCLE K ™ antidiarrheal Loperamide HCI Tablets, USP 2 mg [caplet image] actual size 4 caplets** (2 per pouch)", "Use": "Controls symptoms of diarrhea, including Travelers’ Diarrhea", "50565-1": "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)", "50566-9": "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.", "50567-7": "When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.", "50568-5": "Ask a doctor or pharmacist before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs.", "50569-3": "Ask a doctor before use if you have ■ fever ■ mucus in the stool ■ a history of liver disease ■ a history of abnormal heart rhythm", "50570-1": "Do not use if you have bloody or black stool", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Anti-diarrheal", "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 hour 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", "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.", "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)", "Active ingredient (in each caplet)": "Loperamide HCl, USP 2 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:10.299802 · Updated: 2026-03-14T23:06:36.654428