ANTI DIARRHEAL- loperamide hydrochloride tablet, film coated 
HyVee Inc

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Hy-Vee, Inc. Anti-Diarrheal Drug Facts

Active ingredient (in each caplet)

Loperamide HCl 2 mg

Purpose

Anti-diarrheal

Uses

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

•
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 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 under 6 years (up to 47 lbs)

ask a doctor

Other information

•
store at 20°-25°C (68°-77°F)
•
do not use if blister unit is broken or torn

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

Compare to Imodium® A-D active ingredient

Loperamide Hydrochloride Tablets, 2 mg

Anti-Diarrheal

Controls the symptoms of Diarrhea

Actual Size

*Each caplet (capsule-shaped tablet) contains 2 mg Loperamide Hydrochloride

Anti-Diarrheal Carton Image 1

Anti-Diarrheal Carton Image 1

Anti-Diarrheal Carton Image 2

Anti-Diarrheal Carton Image 1

Anti-Diarrheal Carton Image 2

ANTI DIARRHEAL 
loperamide hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42507-224
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
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorGREENScore2 pieces
ShapeCAPSULESize10mm
FlavorImprint Code L2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42507-224-532 in 1 CARTON03/21/200303/18/2019
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:42507-224-624 in 1 CARTON03/21/200304/29/2019
26 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:42507-224-911 in 1 CARTON03/21/200303/04/2019
36 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:42507-224-801 in 1 CARTON03/21/200306/10/2019
496 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07523203/21/200306/10/2019
Labeler - HyVee Inc (006925671)

Revised: 11/2019
Document Id: 80dbdd39-6640-4705-9d7c-51aeb82334d6
Set id: 9434cefe-6b13-47c4-b2f7-b8d566c5a4ff
Version: 3
Effective Time: 20191121
 
HyVee Inc