LOPERAMIDE HYDROCHLORIDE- loperamide hcl solution

loperamide hydrochloride by

Drug Labeling and Warnings

loperamide hydrochloride by is a Otc medication manufactured, distributed, or labeled by ATLANTIC BIOLOGICALS CORP., UNIT DOSE SOLUTIONS.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 7.5 mL)

Loperamide HCl 1 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 or pharmacist 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 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.
• shake well before using
• use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
• mL = milliliter

• adults and children 12 years and over:

  30 mL after the first loose stool; 15 mL after each subsequent loose stool; but no more than 60 mL in 24 hours

• children 9-11 years (60-95 lbs):

  15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hours

• children 6-8 years (48-59 lbs):

  15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL in 24 hours

• children 2-5 years (34 to 47 lbs):

  ask a doctor

• children under 2 years (up to 33 lbs):

  do not use

Other information

• each 30 mL contains: sodium 15 mg
• store between 20-25°C (68-77°F)

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, D&C yellow no. 10, FD&C blue no. 1, glycerin, microcrystalline cellulose, natural and artificial mint flavor, propylene glycol, purified water, simethicone, sodium benzoate, sucralose, titanium dioxide, xanthan gum

Questions or comments? DISTRIBUTED BY:  ATLANTIC BILOGICALS CORP.20101 N.E 16TH PLACEMIAMI, FL 33179 

1-800-719-9260

Package/Label Principal Display Panel

Compare to the active ingredient in Imodium® A-D

17856-6836-1 Loperamide Hydrochloride Oral Solution, 1 mg per 7.5 mL

17856-6836-2 Loperamide Hydrochloride Oral Solution, 2 mg per 15 mL

Anti-Diarrheal

Controls the symptoms of diarrhea

Mint Flavor - Anti-Diarrheal Oral Solution

SEE NEW WARNING AND DIRECTIONS

INGREDIENTS AND APPEARANCE

LOPERAMIDE HYDROCHLORIDE 
loperamide hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17856-6836(NDC:0904-6836)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II)	LOPERAMIDE HYDROCHLORIDE	1 mg  in 7.5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	GREEN (opaque, viscous)	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17856-6836-1	72 in 1 BOX, UNIT-DOSE	04/21/2020
1		7.5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC: 17856-6836-2	50 in 1 BOX, UNIT-DOSE	04/21/2020
2		15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091292	11/29/2018

Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)

Establishment
Name	Address	ID/FEI	Business Operations
ATLANTIC BIOLOGICALS CORP.		047437707	repack(17856-6836) , relabel(17856-6836)