family wellness 44-375

family wellness 44-375
SPL v24
SPL
SPL Set ID 769e7182-fa11-4645-8fca-657253f28d9c
Route
oral
Published
Effective Date 2025-05-27
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 2005-05-03
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 20º-25ºC (68º-77ºF)
  • 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

Principal Display Panel

FAMILY

Wellness™

*COMPARE TO THE ACTIVE

INGREDIENT IN IMODIUM® A-D

ANTI-

DIARRHEAL

Loperamide HCl Tablets, 2 mg

Anti-diarrheal

Controls the symptoms of diarrhea 

24 CAPLETS

ACTUAL SIZE

NDC 55319-375-08

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS 

OPENED OR IF BLISTER UNIT IS TORN, BROKEN

OR SHOWS ANY SIGNS OF TAMPERING

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

owner of the registered trademark Imodium® A-D.

50844         REV0325B37508

DISTRIBUTED BY: MIDWOOD BRANDS LLC,

500 VOLVO PARKWAY, CHESAPEAKE, VA 23320 USA

NOT 100% SATISFIED? Return within 30 days to the store

of purchase for a refund (with receipt) or exchange.

1. To open, tear

at perforations and

remove a section.

2. Use ✄ to cut

through plastic

for caplet.

Family Wellness 44-375
Use

controls symptoms of diarrhea, including Travelers' Diarrhea

Do Not Use

if you have bloody or black stool.

Questions Or Comments?

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

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 20º-25ºC (68º-77ºF)
  • 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

Principal Display Panel

FAMILY

Wellness™

*COMPARE TO THE ACTIVE

INGREDIENT IN IMODIUM® A-D

ANTI-

DIARRHEAL

Loperamide HCl Tablets, 2 mg

Anti-diarrheal

Controls the symptoms of diarrhea 

24 CAPLETS

ACTUAL SIZE

NDC 55319-375-08

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS 

OPENED OR IF BLISTER UNIT IS TORN, BROKEN

OR SHOWS ANY SIGNS OF TAMPERING

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

owner of the registered trademark Imodium® A-D.

50844         REV0325B37508

DISTRIBUTED BY: MIDWOOD BRANDS LLC,

500 VOLVO PARKWAY, CHESAPEAKE, VA 23320 USA

NOT 100% SATISFIED? Return within 30 days to the store

of purchase for a refund (with receipt) or exchange.

1. To open, tear

at perforations and

remove a section.

2. Use ✄ to cut

through plastic

for caplet.

Family Wellness 44-375
Use

controls symptoms of diarrhea, including Travelers' Diarrhea

Do Not Use (Do not use)

if you have bloody or black stool.

Questions Or Comments? (Questions or comments?)

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

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

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:06:11.361360 · Updated: 2026-03-14T23:08:48.977444