Your browser does not support JavaScript! LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) LIQUID [RITE AID CORPORATION]
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LOPERAMIDE HYDROCHLORIDE (loperamide hcl) liquid
[Rite Aid Corporation]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

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

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
only use attached measuring cup to dose product

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 1/2 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 1/2 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 13 mg
store between 20-25°C (68-77°F)
do not use if printed plastic neckband is broken or missing
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 the active ingredient of Imodium® A-D

loperamide hydrochloride oral suspension

anti-diarrheal

mint flavor

for the control of the symptoms of diarrhea

1 mg loperamide hydrochloride per 7.5 mL

Loperamide Hydrochloride Oral Suspension Label Image 1
Loperamide Hydrochloride Oral Suspension Label Image 2
Loperamide Hydrochloride Oral Suspension Label Image 3
LOPERAMIDE HYDROCHLORIDE 
loperamide hcl liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:11822-1645
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE) LOPERAMIDE HYDROCHLORIDE1 mg  in 7.5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
CARBOXYMETHYLCELLULOSE SODIUM 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
GLYCERIN 
CELLULOSE, MICROCRYSTALLINE 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SUCRALOSE 
TITANIUM DIOXIDE 
XANTHAN GUM 
Product Characteristics
ColorGREEN (opaque, viscous) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-1645-1120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09129205/23/2012
Labeler - Rite Aid Corporation (014578892)

Revised: 9/2013
 
Rite Aid Corporation

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