Welmate Anti-diarrheal (loperamide Hcl) Caplets

Welmate Anti-diarrheal (loperamide Hcl) Caplets
SPL v1
SPL
SPL Set ID ae2e006c-0347-6c35-e053-2a95a90ab7b1
Route
ORAL
Published
Effective Date 2020-08-22
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 Magnesium Stearate Microcrystalline Cellulose Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;375 Shape: oval Color: green Size: 8 mm Score: 2
Marketing Status
ANDA Active Since 2020-08-22
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 to 47 lbs)  ask a doctor
 children under 2 years (up to 33 lbs)  do not use

Questions?

call toll-free 1-800-935-6737

Do Not Use:
  • if you have bloody or black stool
Other Information
  • do not use if blister unit is torn or open
  • store at 20°- 25°C (68° - 77°F)
Package Labeling:

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.

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 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:
  • fever
  • mucus in the stool
  • a history of liver disease
  • a history of abnormal heart rhythm
  • Ask a doctor 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 to 47 lbs)  ask a doctor
 children under 2 years (up to 33 lbs)  do not use

Questions?

call toll-free 1-800-935-6737

Do Not Use: (Do not use:)
  • if you have bloody or black stool
Other Information (Other information)
  • do not use if blister unit is torn or open
  • store at 20°- 25°C (68° - 77°F)
Package Labeling:

Inactive Ingredients (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.

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 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:)
  • fever
  • mucus in the stool
  • a history of liver disease
  • a history of abnormal heart rhythm
  • Ask a doctor 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: 2026-02-15T11:58:40.010277 · Updated: 2026-03-14T22:58:16.152732