HEALTH MART LOPERAMIDE HYDROCHLORIDE- loperamide hydrochloride 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
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

adults and children 12 years and over	30 mL (6 tsp) after the first loose stool; 15 mL (3 tsp) after each subsequent loose stool; but no more than 60 mL (12 tsp) in 24 hours
children 9-11 years (60-95 lbs)	15 mL (3 tsp) after the first loose stool; 7.5 mL (1 ½ tsp) after each subsequent loose stool; but no more than 45 mL (9 tsp) in 24 hours
children 6-8 years (48-59 lbs)	15 mL (3 tsp) after the first loose stool; 7.5 mL (1 ½ tsp) after each subsequent loose stool; but no more than 30 mL (6 tsp) in 24 hours
children under 6 years (up to 47 lbs)	ask a doctor

Other information
- each 30 mL (6 tsp) contains: sodium 15 mg
- store between 20-25°C (68-77°F)
- see side panel for lot number and expiration date
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?

1-800-719-9260
Package/Label Principal Display Panel

compare to Imodium® A-D active ingredient

for ages 6 years and up

loperamide hydrochloride oral suspension

anti-diarrheal liquid

controls the symptoms of diarrhea

mint flavor

1 mg loperamide hydrochloride per 7.5 mL

4 fl oz (120 mL)

INGREDIENTS AND APPEARANCE

HEALTH MART LOPERAMIDE HYDROCHLORIDE
loperamide hydrochloride 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)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 62011-0236-1	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/11/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA091292	06/11/2014

Labeler - Strategic Sourcing Services LLC (116956644)

Health Mart Loperamide Hydrochloride by