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anti diarrheal by Preferred Pharmaceuticals Inc.

Dosage form: tablet, film coated
Ingredients: LOPERAMIDE HYDROCHLORIDE 2mg
Labeler: Preferred Pharmaceuticals Inc.
NDC Code: 68788-8951

Major Pharmaceuticals Anti-Diarrheal Drug Facts

Active ingredient (in each caplet)

Loperamide HCl 2 mg

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 reaction 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
1.
fever
2.
mucus in the stool
3.
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
1.
symptoms get worse
2.
diarrhea lasts for more than 2 days
3.
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 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 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 20°-25°C (68°-77°F)
see end panel for lot number and expiration date

Inactive ingredients

anhydrous lactose, carnauba wax, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch

Questions or comments?

1-800-719-9260

Principal Display Panel

See New Warning and Directions

Loperamide Hydrochloride Tablets, 2 mg

Anti-Diarrheal

Anti-Diarrheal Controls the Symptoms of Diarrhea

Actual Size

*Capsule-Shaped Tablets

COMPARE TO active ingredient of IMODIUM® A-D

ANTI DIARRHEAL 
loperamide hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-8951(NDC:0904-7725)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE) LOPERAMIDE HYDROCHLORIDE2 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
CARNAUBA WAX 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
HYPROMELLOSE, UNSPECIFIED 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
STARCH, CORN 
Product Characteristics
ColorGREENScore2 pieces
ShapeOVALSize10mm
FlavorImprint CodeL2
Contains    
Packaging
#Item CodePackage Description
1NDC:68788-8951-115 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
2NDC:68788-8951-224 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
3NDC:68788-8951-330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
4NDC:68788-8951-660 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07523211/20/2015
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIOperations
Preferred Pharmaceuticals Inc.791119022REPACK(68788-8951)

 
Preferred Pharmaceuticals Inc.

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Medically reviewed on Nov 9, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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