GOOD NEIGHBOR PHARMACY LOPERAMIDE HYDROCHLORIDE- loperamide hcl suspension

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
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.
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?

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Compare to Imodium® A-D active ingredient

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FOR AGES 6 YEARS AND UP

Loperamide

Hydrochloride

Oral Solution, 1 mg per 7.5 mL

anti-diarrheal

Controls the Symptoms of Diarrhea

mint flavor

Anti-Diarrheal Oral Solution

4 fl oz (120 mL)

INGREDIENTS AND APPEARANCE

GOOD NEIGHBOR PHARMACY LOPERAMIDE HYDROCHLORIDE
loperamide hcl suspension

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 46122-546-26	1 in 1 CARTON	08/23/2018
1		120 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA091292	08/23/2018

Labeler - Amerisource Bergen (007914906)

Good Neighbor Pharmacy Loperamide Hydrochloride by