STOMACH RELIEF ANTI DIARRHEAL- loperamide hydrochloride tablet

Stomach Relief Anti Diarrheal by

Drug Labeling and Warnings

Stomach Relief Anti Diarrheal by is a Otc medication manufactured, distributed, or labeled by Select Corporation, Ohm Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Loperamide HCl 2 mg

PURPOSE

Anti Diarrheal

DOSAGE

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
under 6 years (up to 47 lbs): ask a doctor

INDICATIONS & USAGE

controls the 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 HCI

if you have bloody or black stool Ask a doctor before use

if you have: fever mucus in 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

PREGNANCY

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

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

INACTIVE INGREDIENT

Inactive
Ingredients: anhydrous lactose, croscarmellose sodium, crospovidone, DC yellow no. 10, FDC blue no. 1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch

LABEL DISPLAY PANEL

MM1

INGREDIENTS AND APPEARANCE

STOMACH RELIEF ANTI DIARRHEAL  
loperamide hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52904-443
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
LACTOSE (UNII: J2B2A4N98G)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (UNII: 2S7830E561)
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)

Product Characteristics
Color	green (pea green)	Score	no score
Shape	CAPSULE (123)	Size	10mm
Flavor		Imprint Code	123
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52904-443-50	25 in 1 BOX	10/15/2012
1	NDC: 52904-443-06	1 in 1 CARTON
1	NDC: 52904-443-02	2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074091	10/15/2012

Labeler - Select Corporation (053805599)

Establishment
Name	Address	ID/FEI	Business Operations
Select Corporation		053805599	label(52904-443)

Establishment
Name	Address	ID/FEI	Business Operations
Ohm Laboratories Inc.		184769029	manufacture(52904-443)