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 Product08/25/2016
2NDC:68788-7369-112 in 1 BOTTLE; Type 0: Not a Combination Product06/21/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07649708/25/2016
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals Inc.791119022RELABEL(68788-7369)

Revised: 7/2023
Document Id: d92f1b08-19ef-40ec-91bd-d995c612e78c
Set id: 1514e697-f034-4b81-88a9-5f424d736a6a
Version: 7
Effective Time: 20230725
 
Preferred Pharmaceuticals Inc.