OTC Medication Information: Loperamide Hydrochloride

LOPERAMIDE HYDROCHLORIDE- loperamide hydrochloride solution
ATLANTIC BIOLOGICALS CORP.

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 PLACE MIAMI, 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

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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE) LOPERAMIDE HYDROCHLORIDE 1 mg in 7.5 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
D&C YELLOW NO. 10
FD&C BLUE NO. 1
GLYCERIN
MICROCRYSTALLINE CELLULOSE
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
SUCRALOSE
TITANIUM DIOXIDE
XANTHAN GUM
DIMETHICONE
SILICON DIOXIDE
Product Characteristics
Color GREEN (opaque, viscous) Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:17856-6836-1 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE contains a CUP, UNIT-DOSE (17856-6836-3)
1 NDC:17856-6836-3 7.5 mL in 1 CUP, UNIT-DOSE This package is contained within the BOX, UNIT-DOSE (17856-6836-1)
2 NDC:17856-6836-2 50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE contains a CUP, UNIT-DOSE (17856-6836-4)
2 NDC:17856-6836-4 15 mL in 1 CUP, UNIT-DOSE This package is contained within the BOX, UNIT-DOSE (17856-6836-2)
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 Operations
UNIT DOSE SOLUTIONS. 360804194 repack (17856-6836)

Revised: 09/2022 ATLANTIC BIOLOGICALS CORP.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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