DailyMed - DailyMed Details

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 Magnesium Stearate Microcrystalline Cellulose Silicon Dioxide

Identifiers & Packaging

Marketing Status

ANDA Active Since 2021-10-20

Medication Information

Purpose

Anti-diarrheal

Description

Loperamide HCl 2mg

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

Section 50568-5

Ask a doctor or pharmacist before use if you are taking antibiotics

Section 50569-3

Ask a doctor before use if you have

fever
mucus in the stool
a history of liver disease

Section 50570-1

Do not use if you have bloody or black stool

Section 51945-4

Loperamide Hydrochloride Tablets, 2 mg

Anti-Diarrheal

Controls the Symptoms of Diarrhea

*Compare to active ingredient of Imodium A-D®

DO NOT USE IF BLISTER UNIT IS BROKEN OR TORN

Actual size

12 CAPLETS** Anti-Diarrheal

**Capsule-Shaped Tablet

Section 53414-9

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

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

Active Ingredient

Loperamide HCl 2mg

Other Information

store at 20°-25°C (68°-77°F)
avoid excessive heat above 40°C (104°F)
do not use blister unit is broken or torn

Inactive Ingredients

corn starch, D&C yellow #10 aluminum lake, dicalcium phosphate dihydrate, FD&C blue #1 brilliant blue lake, magnesium stearate, microcrystalline cellulose, silica gel

Structured Label Content

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 product tiredness, 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 are taking antibiotics

Section 50569-3 (50569-3)

Ask a doctor before use if you have

fever
mucus in the stool
a history of liver disease

Section 50570-1 (50570-1)

Do not use if you have bloody or black stool

Section 51945-4 (51945-4)

Loperamide Hydrochloride Tablets, 2 mg

Anti-Diarrheal

Controls the Symptoms of Diarrhea

*Compare to active ingredient of Imodium A-D®

DO NOT USE IF BLISTER UNIT IS BROKEN OR TORN

Actual size

12 CAPLETS** Anti-Diarrheal

**Capsule-Shaped Tablet

Section 53414-9 (53414-9)

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

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

Active Ingredient

Loperamide HCl 2mg

Other Information (Other information)

store at 20°-25°C (68°-77°F)
avoid excessive heat above 40°C (104°F)
do not use blister unit is broken or torn

Inactive Ingredients

corn starch, D&C yellow #10 aluminum lake, dicalcium phosphate dihydrate, FD&C blue #1 brilliant blue lake, magnesium stearate, microcrystalline cellulose, silica gel

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", "unii": "H3R47K3TBD", "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", "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 antibiotics", "50569-3": "Ask a doctor before use if you have fever mucus in the stool a history of liver disease", "50570-1": "Do not use if you have bloody or black stool", "51945-4": "Loperamide Hydrochloride Tablets, 2 mg Anti-Diarrheal Controls the Symptoms of Diarrhea *Compare to active ingredient of Imodium A-D® DO NOT USE IF BLISTER UNIT IS BROKEN OR TORN Actual size 12 CAPLETS** Anti-Diarrheal **Capsule-Shaped Tablet", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "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 ", "Active Ingredient": "Loperamide HCl 2mg", "Other information": "store at 20°-25°C (68°-77°F) avoid excessive heat above 40°C (104°F) do not use blister unit is broken or torn", "Inactive Ingredients": "corn starch, D&C yellow #10 aluminum lake, dicalcium phosphate dihydrate, FD&C blue #1 brilliant blue lake, magnesium stearate, microcrystalline cellulose, silica gel"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information