Anti-diarrheal, Lil' Drug Store ®

Anti-diarrheal, Lil' Drug Store ®
SPL v7
SPL
SPL Set ID fc23b13e-3005-4f23-aec2-b02a0e48ea11
Route
ORAL
Published
Effective Date 2022-05-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loperamide (2 mg)
Inactive Ingredients
Anhydrous Lactose Croscarmellose Sodium Crospovidone (15 Mpa.s At 5%) D&c Yellow No. 10 Fd&c Blue No. 1 Magnesium Stearate Powdered Cellulose Starch, Corn Glyceryl Tristearate

Identifiers & Packaging

Pill Appearance
Imprint: 123 Shape: oval Color: green Size: 10 mm Score: 2
Marketing Status
ANDA Active Since 2012-09-14 Until 2021-09-12

Description

Drug Facts

Purpose

Anti-diarrheal


Medication Information

Purpose

Anti-diarrheal

Description

Drug Facts

Use

Controls symptoms of diarrhea, including Travelers' Diarrhea

Section 42229-5

Drug Facts

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 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 a prescription drug. Loperamide may interact with certain prescription drugs.

Section 50570-1

Do not use if you have bloody or black stool

Section 53414-9

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

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

(up to 33 lbs)
do not use
Heart Alert

Taking more than directed can cause serious heart problems or death.

Allergy Alert

Do not use if you have ever had a rash or other allergic reaction to Loperamide HCl.

Other Information
  • store between 68-77°F (20-25°C)
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?

call toll-free 1-877-507-6516 (M-F 8AM - 4:30PM CST)

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.
Active Ingredient (in Each Caplet)

Loperamide HCl, USP 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
Principal Display Panel 2 Mg Caplet Pouch Carton

QUALITY

⋆ GUARANTEED ⋆

Compare to the Active

Ingredient in Imodium® A-D*

Anti-

Diarrheal

on

the

Go

PACKS

See New Warning & Directions

Anti-Diarrheal

Loperamide HCl Tablets, USP 2 mg

• Controls the Symptoms of Diarrhea

4

Caplets**

2 POUCHES, 2 CAPLETS PER POUCH

Lil'

Drug Store ®

Anti Diarrheal Dispens It, 25pc, Lil' Drug Store ®

COMPARE TO THE ACTIVE INGREDIENT IN

Imodium ® A-D*

Anti-Diarrheal

Loperamide HCl Tablets, USP 2 mg

  • Controls the Symptoms

of Diarrhea

[tablet image]

Actual Size

This product not for households

with small children.

1 CAPLET PER POUCH

[Lil' Drug Store ® logo]

Anti Diarrheal Dispens It, 30pc, Lil' Drug Store ®

COMPARE TO THE ACTIVE INGREDIENT IN

Imodium ® A-D*

Anti-Diarrheal

Loperamide HCl Tablets, USP 2 mg

  • Controls the Symptoms

of Diarrhea

[tablet image]

Actual Size

This product not for households

with small children.

1 CAPLET PER POUCH

[Lil' Drug Store ® logo]


Structured Label Content

Use

Controls symptoms of diarrhea, including Travelers' Diarrhea

Section 42229-5 (42229-5)

Drug Facts

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 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 a prescription drug. Loperamide may interact with certain prescription drugs.

Section 50570-1 (50570-1)

Do not use if 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
  • 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

(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)

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

Loperamide HCl, USP 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
Principal Display Panel 2 Mg Caplet Pouch Carton (PRINCIPAL DISPLAY PANEL - 2 mg Caplet Pouch Carton)

QUALITY

⋆ GUARANTEED ⋆

Compare to the Active

Ingredient in Imodium® A-D*

Anti-

Diarrheal

on

the

Go

PACKS

See New Warning & Directions

Anti-Diarrheal

Loperamide HCl Tablets, USP 2 mg

• Controls the Symptoms of Diarrhea

4

Caplets**

2 POUCHES, 2 CAPLETS PER POUCH

Lil'

Drug Store ®

Anti Diarrheal Dispens It, 25pc, Lil' Drug Store ® (Anti-Diarrheal Dispens-It, 25pc, Lil' Drug Store ®)

COMPARE TO THE ACTIVE INGREDIENT IN

Imodium ® A-D*

Anti-Diarrheal

Loperamide HCl Tablets, USP 2 mg

  • Controls the Symptoms

of Diarrhea

[tablet image]

Actual Size

This product not for households

with small children.

1 CAPLET PER POUCH

[Lil' Drug Store ® logo]

Anti Diarrheal Dispens It, 30pc, Lil' Drug Store ® (Anti-Diarrheal Dispens-It, 30pc, Lil' Drug Store ®)

COMPARE TO THE ACTIVE INGREDIENT IN

Imodium ® A-D*

Anti-Diarrheal

Loperamide HCl Tablets, USP 2 mg

  • Controls the Symptoms

of Diarrhea

[tablet image]

Actual Size

This product not for households

with small children.

1 CAPLET PER POUCH

[Lil' Drug Store ® logo]


Advanced Ingredient Data


Raw Label Data

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