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Stomach Relief Anti Diarrheal

Dosage form: tablet
Ingredients: LOPERAMIDE HYDROCHLORIDE 2mg
Labeler: Select Corporation
NDC Code: 52904-443

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 ANTI DIARRHEAL  
loperamide hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52904-443
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE) LOPERAMIDE HYDROCHLORIDE2 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE 
CROSCARMELLOSE SODIUM 
CROSPOVIDONE 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
MAGNESIUM STEARATE 
POWDERED CELLULOSE 
STARCH, CORN 
Product Characteristics
Colorgreen (pea green) Scoreno score
ShapeCAPSULE (123) Size10mm
FlavorImprint Code123
Contains    
Packaging
#Item CodePackage Description
1NDC:52904-443-5025 CARTON in 1 BOX
1NDC:52904-443-061 PACKET in 1 CARTON
1NDC:52904-443-022 TABLET in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07409110/15/2012
Labeler - Select Corporation (053805599)
Establishment
NameAddressID/FEIOperations
Select Corporation053805599label(52904-443)
Establishment
NameAddressID/FEIOperations
Ohm Laboratories Inc.184769029manufacture(52904-443)

Revised: 10/2012
 
Select Corporation

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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