ANTI-DIARRHEAL- loperamide hci tablet

Anti-Diarrheal by

Drug Labeling and Warnings

Anti-Diarrheal by is a Otc medication manufactured, distributed, or labeled by Mechanical Servants, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient ( in each tablet)

Loperamide HCl, USP 2 mg

Purpose

Anti-diarrheal

Use

Controls symptoms of diarrhea, including Travelers’ Diarrhea

Warnings

Allergy alert

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

Heart alert

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 hour

• 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

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 1-800-351-2000 (8:30 AM - 5:00 PM CST)

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc, McNeil Consumer Healthcare Divison, distributor of Imodium® A-D

Distributed by: Lil’ Drug Store Products, Inc., Cedar Rapids, IA 52404

2 mg Loperamide Tablet

Compare to the active ingredient in Imodium® A-D*

Diamode

Anti-Diarrheal Relief

Loperamide HCl

Tablets, USP 2 mg

[tablet image]

actual size

1 CAPLET IN EACH PACKET

READ DRUG FACTS AND INSTRUCTIONS ON PACKET

INGREDIENTS AND APPEARANCE

ANTI-DIARRHEAL 
loperamide hci tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29485-9286
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
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)

Product Characteristics
Color	green	Score	no score
Shape	OVAL	Size	9mm
Flavor		Imprint Code	123
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29485-9286-2	25 in 1 BOX	07/27/2016
1		1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 29485-9286-3	30 in 1 BOX	07/27/2016
2		1 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	07/27/2016

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