LIL DRUG STORE ANTI-DIARRHEAL- loperamide hydrochloride tablet

Lil Drug Store Anti-Diarrheal by

Drug Labeling and Warnings

Lil Drug Store Anti-Diarrheal by is a Otc medication manufactured, distributed, or labeled by Lil' Drug Store Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each caplet)

Loperamide HCl, USP 2 mg

Purpose

Anti-diarrheal

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.

Do not use if you have bloody or black stool

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.

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. (1-800-222-1222)

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

Questions or comments?

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

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®

INGREDIENTS AND APPEARANCE

LIL DRUG STORE ANTI-DIARRHEAL 
loperamide hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66715-9859
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II)	LOPERAMIDE HYDROCHLORIDE	2 mg

Inactive Ingredients
Ingredient Name	Strength
Anhydrous Lactose (UNII: 3SY5LH9PMK)
Croscarmellose Sodium (UNII: M28OL1HH48)
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
D&C Yellow No. 10 (UNII: 35SW5USQ3G)
FD&C Blue No. 1 (UNII: H3R47K3TBD)
Magnesium Stearate (UNII: 70097M6I30)
Powdered Cellulose (UNII: SMD1X3XO9M)
STARCH, CORN (UNII: O8232NY3SJ)
GLYCERYL TRISTEARATE (UNII: P6OCJ2551R)

Product Characteristics
Color	GREEN	Score	2 pieces
Shape	OVAL	Size	10mm
Flavor		Imprint Code	123
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66715-9859-2	1 in 1 CARTON	09/01/2014
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 66715-9859-7	50 in 1 CARTON	06/20/2016	09/12/2021
2		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074091	09/14/2012

Labeler - Lil' Drug Store Products, Inc. (093103646)