VAPRINO A-D- loperamide hydrochloride tablet 
Boehringer Ingelheim Pharmaceuticals, Inc.

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Drug Facts

Active ingredient (in each caplet)Purpose
Loperamide HCl 2 mg .............................................................................................................................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.

Do not use if you have bloody or black stool.

Ask a doctor before use if you have • a 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, 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 (1-800-222-1222) right away.

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

Other information

• store between 20˚-25˚C (68˚-77˚F) • do not use if carton or blister unit is open or torn

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? 1-888-285-9159 (English/Spanish), M – F, 8:30 – 5 EST, or www.Vaprino.com

Vaprino Carton
NDC: 0597-0158-14

carton10009008-001

Vaprino Carton
NDC: 0597-0158-48

carton10009050-001
VAPRINO A-D 
loperamide hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0597-0158
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
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorGREEN (light green) Score2 pieces
ShapeOVALSize10mm
FlavorImprint Code V;AD
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0597-0158-142 in 1 CARTON09/02/201310/01/2016
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0597-0158-488 in 1 CARTON09/02/201310/01/2016
26 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07649709/02/201310/01/2016
Labeler - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)
Registrant - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837MANUFACTURE(0597-0158)

Revised: 7/2017
Document Id: 77fb5f99-9c96-35c4-c4ae-fa3c28951536
Set id: c6cc4c7b-0c71-4c5a-37b9-731decaf2eb4
Version: 2
Effective Time: 20170723
 
Boehringer Ingelheim Pharmaceuticals, Inc.