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NDC 17856-6836-02 loperamide hydrochloride 1 mg/7.5mL Details

loperamide hydrochloride 1 mg/7.5mL

loperamide hydrochloride is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by ATLANTIC BIOLOGICALS CORP.. The primary component is LOPERAMIDE HYDROCHLORIDE.

Product Information

NDC	17856-6836
Product ID	17856-6836_115f8f0d-fb6d-46c4-ab4f-e4a4676aeacc
Associated GPIs
GCN Sequence Number	059430
GCN Sequence Number Description	loperamide HCl LIQUID 1MG/7.5ML ORAL
HIC3	D6D
HIC3 Description	ANTIDIARRHEALS
GCN	25065
HICL Sequence Number	001236
HICL Sequence Number Description	LOPERAMIDE HCL
Brand/Generic	Generic
Proprietary Name	loperamide hydrochloride
Proprietary Name Suffix	n/a
Non-Proprietary Name	loperamide HCl
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	1
Active Ingredient Units	mg/7.5mL
Substance Name	LOPERAMIDE HYDROCHLORIDE
Labeler Name	ATLANTIC BIOLOGICALS CORP.
Pharmaceutical Class	Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA091292
Listing Certified Through	2023-12-31

Package

Package Images

NDC 17856-6836-02 (17856683602)

Pricing Information	N/A
NDC Package Code	17856-6836-2
Billing NDC	17856683602
Package	50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-6836-2) / 15 mL in 1 CUP, UNIT-DOSE (17856-6836-4)
Marketing Start Date	2022-09-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7030f4ed-3cd1-428e-9cae-3b14933d41f5 Details

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:17856-6836-1	72 in 1 BOX, UNIT-DOSE	09/21/2022
1	NDC:17856-6836-3	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	09/21/2022
2	NDC:17856-6836-4	15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

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

Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)

Name	Address	ID/FEI	Business Operations
Establishment
UNIT DOSE SOLUTIONS.		360804194	repack(17856-6836)

Revised: 9/2022

Document Id: 115f8f0d-fb6d-46c4-ab4f-e4a4676aeacc

Set id: 7030f4ed-3cd1-428e-9cae-3b14933d41f5

Version: 2

Effective Time: 20220921