Your browser does not support JavaScript! DG HEALTH LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) LIQUID [DOLGENCORP INC]
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DG HEALTH LOPERAMIDE HYDROCHLORIDE (loperamide hcl) liquid
[Dolgencorp Inc]


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?

1-888-309-9030

Package/Label Principal Display Panel

Loperamide Hydrochloride Oral Suspension

Anti-Diarrheal

Compare to active ingredient of Imodium® A-D

Controls the Symptoms of Diarrhea

Mint Flavor

1 mg Loperamide Hydrochloride per 7.5 mL

Loperamide Hydrochloride Oral Suspension Image 1
Loperamide Hydrochloride Oral Suspension Label Image
DG HEALTH LOPERAMIDE HYDROCHLORIDE 
loperamide hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-645
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 Description
1NDC:55910-645-26120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09129207/26/2012
Labeler - Dolgencorp Inc (068331990)

Revised: 10/2012
Document Id: 60546513-376c-4707-b554-2f65a0d24bc1
Set id: 60546513-376c-4707-b554-2f65a0d24bc1
Version: 1
Effective Time: 20121008
 
Dolgencorp Inc

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