DZA Brands, LLC Anti-Diarrheal Drug Facts

healthy accents anti diarrheal by

Drug Labeling and Warnings

healthy accents anti diarrheal by is a Otc medication manufactured, distributed, or labeled by DZA Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEALTHY ACCENTS ANTI DIARRHEAL- loperamide hydrochloride tablet, film coated 
DZA Brands LLC

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DZA Brands, LLC Anti-Diarrheal Drug Facts

Active ingredient (in each caplet)

Loperamide HCl 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 HCl

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

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. (1-800-222-1222)

Directions

• drink plenty of clear fluids 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 under 6 years (up to 47 lbs):

  ask a doctor

Other information

• store at 20°-25°C (68°-77°F)
• do not use if blister unit is broken or torn

Inactive ingredients

anhydrous lactose, carnauba wax, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch

Questions or comments?

1-866-322-2439

Principal Display Panel

loperamide hydrochloride tablets, 2 mg

anti-diarrheal

controls the symptoms of diarrhea, including travelers' diarrhea

Compare To Imodium® A-D active ingredient

actual size

*each caplet (capsule-shaped tablet) contains 2 mg Loperamide hydrochloride

Anti-Diarrheal Carton Image 1

Anti-Diarrheal Carton Image 1

Anti-Diarrheal Carton Image 2

HEALTHY ACCENTS ANTI DIARRHEAL 
loperamide hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55316-224
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
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CARNAUBA WAX (UNII: R12CBM0EIZ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	GREEN	Score	2 pieces
Shape	CAPSULE	Size	10mm
Flavor		Imprint Code	L2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55316-224-53	2 in 1 CARTON	03/10/2008	05/26/2019
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 55316-224-62	4 in 1 CARTON	02/04/2008	09/30/2019
2		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 55316-224-80	1 in 1 CARTON	06/23/2011	07/09/2019
3		96 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075232	02/04/2008	09/30/2019

Labeler - DZA Brands LLC (090322194)

Revised: 11/2019

Document Id: ecf49b96-ba44-4945-aa99-c85088407bfe

34390-5

Set id: 3749411c-423e-4e3b-b017-f8656399f4d3

Version: 2

Effective Time: 20191113

 

DZA Brands LLC