welmate 44-375

welmate 44-375
SPL v4
SPL
SPL Set ID e3b0a274-8bf9-4d39-a805-97fecca607f6
Route
oral
Published
Effective Date 2025-04-08
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 active Since 2024-02-21

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 to 47 lbs) ask a doctor
children under 2 years (up to 33 lbs) do not use
Other Information
  • each caplet contains: calcium 15 mg
  • 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

Use

controls symptoms of diarrhea, including Travelers' Diarrhea

Do Not Use

if you have bloody or black stool

Principal Display Pane

NDC 73581-171-24

Compare to the active ingredient

in Imodium® A-D

Anti-Diarrheal Caplets

Loperamide HCl Tablets, 2 mg

Anti-Diarrheal

- controls symptoms of diarrhea

- suitable for adults and children

  6 years and over

Actual Size

welmate™

24 Caplets*

*Capsule-Shaped Tablets

TAMPER EVIDENT: DO NOT USE IF

PACKAGE IS OPENED OR IF

BLISTER UNIT IS TORN, BROKEN

OR SHOWS ANY SIGNS OF

TAMPERING

1. To open, tear

at perforations and

remove a section.

2. Use ✄ to cut

through plastic

for caplet.

This product is not manufactured or distributed by Kenvue Inc.,

owner of the registered trademark Imodium® A-D.

Distributed by: Wellspring Airmont, NY 10952, USA         50844    ORG032537508

Why pay more?

wellspringmeds.com

Welmate 44-375 REV0325
Questions Or Comments?

Call toll-free 866-933-6337

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
  • 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 to 47 lbs) ask a doctor
children under 2 years (up to 33 lbs) do not use
Other Information (Other information)
  • each caplet contains: calcium 15 mg
  • 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

Use

controls symptoms of diarrhea, including Travelers' Diarrhea

Do Not Use (Do not use)

if you have bloody or black stool

Principal Display Pane

NDC 73581-171-24

Compare to the active ingredient

in Imodium® A-D

Anti-Diarrheal Caplets

Loperamide HCl Tablets, 2 mg

Anti-Diarrheal

- controls symptoms of diarrhea

- suitable for adults and children

  6 years and over

Actual Size

welmate™

24 Caplets*

*Capsule-Shaped Tablets

TAMPER EVIDENT: DO NOT USE IF

PACKAGE IS OPENED OR IF

BLISTER UNIT IS TORN, BROKEN

OR SHOWS ANY SIGNS OF

TAMPERING

1. To open, tear

at perforations and

remove a section.

2. Use ✄ to cut

through plastic

for caplet.

This product is not manufactured or distributed by Kenvue Inc.,

owner of the registered trademark Imodium® A-D.

Distributed by: Wellspring Airmont, NY 10952, USA         50844    ORG032537508

Why pay more?

wellspringmeds.com

Welmate 44-375 REV0325
Questions Or Comments? (Questions or comments?)

Call toll-free 866-933-6337

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)
  • 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


Raw Label Data

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