Anti-Diarrheal by Freds Inc Drug Facts

Drug Details [pdf]

ANTI-DIARRHEAL- loperamide hydrochloride capsule, liquid filled
Freds Inc

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Drug Facts

Active Ingredient (in each capsule)

Loperamide HCI 2 mg

Purpose

Anti- diarrheal

Use

controls symptoms of diarrhea, including Traveler's 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 problem or death

Do not use

if you have bloody or black stool
in children under 12 years of age

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 gets 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 Certer right away.

Directions

drink plenty of clear fluids to help prevent dehydration caused by diarrhea
not for use in children under 12 years of age
adults and children 12 years of age and over: 2 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels in 24 hours

Other information

store at 20o-25o C (68o-77o F). Protect from light.
avoid excessive heat above 40°C (104°F).
do not use if carton or blister unit is open or torn
see side panel for lot number and expiration date

Inactive Ingredients

butylated hydroxyanisole, edible ink, FD&C Blue #1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil and purified water.

Questions or comments?

call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Anti-Diarrheal

Loperamide HCl, 2mg

Controls the symptoms of diarrhea

Suitable For Adults And Children 12 Years And Over

SOFTGELS**

**EACH LIQUID-FILLED CAPSULE CANTAINS 2 MG LOPERAMIDE HCl

Compare To The Active Ingredients in Imodium® A-D*

THIS PRODUCT IS PACKAGED IN A CHILD-RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

*This product is not manufactured or distributed by McNeil Consumer & Specialty Pharmaceuticals, distributor of Imodium® A-D.

DISTRIBUTED BY: fred's, Inc.

4300 NEW GETWELL RD,,

MEMPHIS, TN 38118

www.fredsinc.com

Product Label

FRED'S PHARMACY Anti-Diarrheal

ANTI-DIARRHEAL
loperamide hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55315-520
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II)	LOPERAMIDE HYDROCHLORIDE	2 mg

Ingredient Name	Strength
Inactive Ingredients
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	BLUE	Score	no score
Shape	CAPSULE	Size	10mm
Flavor		Imprint Code	P13
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 55315-520-24	2 in 1 CARTON	07/08/2010	12/31/2019
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA021855	07/08/2010	12/31/2019

Labeler - Freds Inc (005866116)

Revised: 12/2018

Document Id: f71384f9-4865-4b88-963b-d81e578fb6d7

Set id: 984f0b01-cc7b-4ca1-9299-fd031cbc94bf

Version: 5

Effective Time: 20181212

Freds Inc