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

Purpose

Anti-diarrheal

Description

Drug Facts


Medication Information

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
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

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.

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.

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

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
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

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.

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.

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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