ANTI-DIARRHEAL- loperamide hcl tablet 
Preferred Pharmaceuticals Inc.

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Active ingredient(in each caplet)

Loperamide HCI 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 HCI

Do not use

•
if you have bloody or black stool

Ask a doctor before use if you have

•
fever
•
mucus present in your 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

•
diarrhea lasts for more than 2 days
•
symptoms get worse
•
you get abdominal swelling
•
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.

Directions

drink plenty of clear fluids to help prevent dehydration,which may accompany diarrhea

•
do not exceed recommended dose
•
Adults and children 12 years and over: 2 caplets after the first loose bowel movement; 1 caplet after each subsequent loose bowel movement; do not exceed 4 caplets in 24 hours
•
Children under 12 years: Ask a doctor

Other Information

•
TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
•
store at 20⁰C-25⁰C (68⁰F-77⁰F)

Inactive Ingredients

cellulose, corn starch, D C Yellow #10, dicalcium phosphate, FD C Blue #1, magnesium stearate, silica gel

Questions or comments? call 1-800-540-3765

package Label


NDC 68788-7369-2

GERICARE

Anti-Diarrheal

Loperamide HCl

Controls the symptoms of diarrhea

*compare to the active ingredient in imodium A-D

24 caplets

2 mg each

Tamper Evident: Do not use if imprinted seal under cap is broken or missing

Relabeled By: Preferred Pharmaceuticals Inc.

Loperamide HCL Tablets, USP 2mg
ANTI-DIARRHEAL 
loperamide hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-7369(NDC:57896-381)
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 DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
Colorgreen (light green) Score2 pieces
ShapeCAPSULESize7mm
FlavorImprint Code 44375
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68788-7369-224 in 1 BOTTLE; Type 0: Not a Combination Product08/25/201606/25/2024
2NDC:68788-7369-112 in 1 BOTTLE; Type 0: Not a Combination Product06/21/201706/25/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07649708/25/201606/25/2024
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals Inc.791119022RELABEL(68788-7369)

Revised: 6/2024
Document Id: ca2cd108-ffa0-4324-9a86-2f46ae0798cd
Set id: 1514e697-f034-4b81-88a9-5f424d736a6a
Version: 8
Effective Time: 20240625
 
Preferred Pharmaceuticals Inc.