ANTI-DIARRHEAL- loperamide hydrochloride tablet

Anti-Diarrheal by

Drug Labeling and Warnings

Anti-Diarrheal by is a Otc medication manufactured, distributed, or labeled by Advanced Rx LLC, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each caplet)

Loperamide HCl 2 mg

Purpose

Anti-diarrheal

Use

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.

Heart alert: Taking more than directed can cause serious heart problems or death.

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
• a history of abnormal heart rhythm

Ask a doctor before use if you are

taking a prescription drug. Loperamide may interact with certain prescription drugs.

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 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 (1-800-222-1222) right away.

Directions

• drink plenty of clear liquid 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 2-5 years (34-47 lbs): ask a doctor
• children under 2 years (up to 33 lbs): do not use

Other information

• do not use if seal around caplet is broken or damaged
• store between  20° and 25°C (68° and 77°F)
• KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
• THIS PRODUCT IS PACKAGED IN A CHILD-RESISTANT AND TEMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

Inactive ingredients

corn starch, D&C yellow#10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue#1 brilliant blue lake, magnesium stearate, microcrystalline cellulose, silica gel.

Questions?

call toll-free 1-800-630-8895

SPL UNCLASSIFIED SECTION

Distributed by:

ADVANCED RX LLC,

1942 NE 163rd St,

North Miami Beach,

FL 33162 U.S.A.

Principal Display Panel

NDC: 80513-401-24

Compare to the active ingredient in Imodium ®A-D*

Anti-Diarrheal

Loperamide Hydrocholoride Caplets, 2 mg

Controls Symptoms of Diarrhea

Easy To Swallow

24 CAPLETS

*This product is not manufactured or distributed by the owner of the registered trademark Imodium ®A-D.

INGREDIENTS AND APPEARANCE

ANTI-DIARRHEAL 
loperamide hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80513-401
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
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	green	Score	2 pieces
Shape	OVAL	Size	10mm
Flavor		Imprint Code	44;375
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80513-401-24	4 in 1 CARTON	08/11/2024
1		6 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
ANDA	ANDA076497	01/01/2024

Labeler - Advanced Rx LLC (042795108)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	manufacture(80513-401) , label(80513-401) , pack(80513-401)