STOMACH RELIEF ANTI DIARRHEAL - loperamide hydrochloride tablet 
Select Corporation

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Drug Facts

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.

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

Stomach Relief packet

STOMACH RELIEF ANTI DIARRHEAL  
loperamide hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52904-443
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE2 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorgreen (pea green) Scoreno score
ShapeCAPSULE (123) Size10mm
FlavorImprint Code 123
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52904-443-5025 in 1 BOX10/15/2012
1NDC:52904-443-061 in 1 CARTON
1NDC:52904-443-022 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07409110/15/2012
Labeler - Select Corporation (053805599)
Establishment
NameAddressID/FEIBusiness Operations
Select Corporation053805599label(52904-443)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.184769029manufacture(52904-443)

Revised: 10/2012
Document Id: 21a6698d-3c80-4dfa-98d9-afd5546822b4
Set id: de26457a-55a6-4fad-96d9-04697e157c09
Version: 2
Effective Time: 20121015
 
Select Corporation