ANTI-DIARRHEAL- loperamide hcl tablet, coated

Anti-Diarrheal by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient (in each caplet)

Loperamide HCl 2mg

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 reactions 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

Ask a doctor or pharmacist before use if you are

taking antibiotics

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,

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 (1-800-222-1222) right away.

Directions

• drink plenty of clear fluids to help prevent dehydration caused by diarrhea
• find right dose below. 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; ½ 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; ½ 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

■ store at 20º-25ºC (68º-77º F)   ■ avoid excessive heat above 40ºC (104ºF)

Inactive ingredients

corn starch, D&C yellow #10 aluminum lake, dicalcium phosphate dihydrate, FD&C blue #1 brilliant blue lake, magnesium stearate, microcrystalline cellulose, silica gel

Questions

Call 1-888-952-0050 Monday-Friday 9AM-5PM EST

Principal Display Panel

 Health A2Z®

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

Anti-Diarrheal

Loperamide HCl 2mg

Controls the symptoms of diarrhea

(pill image)

12 CAPLETS

Anti-Diarrheal 12ct. Caplets

INGREDIENTS AND APPEARANCE

ANTI-DIARRHEAL 
loperamide hcl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69168-248
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
STARCH, CORN (UNII: O8232NY3SJ)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	GREEN	Score	2 pieces
Shape	CAPSULE	Size	10mm
Flavor		Imprint Code	44;375
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69168-248-86	2 in 1 CARTON	05/03/2005
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076497	05/03/2005

Labeler - Allegiant Health (079501930)

Establishment
Name	Address	ID/FEI	Business Operations
Allegiant Health		079501930	ANALYSIS(69168-248) , LABEL(69168-248) , PACK(69168-248)