ANTI-DIARRHEAL LOPERAMIDE HCL- loperamide hydrochloride capsule, liquid filled

Anti-Diarrheal by

Drug Labeling and Warnings

Anti-Diarrheal by is a Otc medication manufactured, distributed, or labeled by Strategic Sourcing Services LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 problems 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 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.

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 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-25oC (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, FDandC 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

COMPARE TO IMODIUM® A-D ACTIVE INGREDIENT*

loperamide HCI, 2 mg

Anti-Diarrheal

Soft Gelatin Capsules

Controls the symptoms of diarrhea

Suitable for adults and children 12 years and over

SOFTGELS**

**each Liquid-capsule contains 2 mg Loperamide HCl

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.

Another Quality Product Distributed by McKesson

One Post Street, San Francisco, CA 94104

Please visit us at www.sunmarkbrand.com

Product Label

SUNMARK Anti-Diarrheal Capsules

INGREDIENTS AND APPEARANCE

ANTI-DIARRHEAL  LOPERAMIDE HCL
loperamide hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49348-752
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49348-752-04	2 in 1 BOX	08/01/2006	12/30/2021
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021855	08/01/2006	12/30/2021

Labeler - Strategic Sourcing Services LLC (116956644)