Label: SUNMARK LOPERAMIDE HYDROCHLORIDE- loperamide hydrochloride suspension
- NDC Code(s): 49348-999-34
- Packager: McKesson
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient (in each 7.5 mL)
Loperamide HCl 1 mgClose
controls symptoms of diarrhea, including Travelers’ DiarrheaClose
Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCl
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.
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)
- 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
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
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
(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 gumClose
- Questions or comments?
- Package/Label Principal Display Panel
COMPARE TO IMODIUM® A-D ACTIVE INGREDIENT
loperamide hydrochloride oral suspension
CONTROLS THE SYMPTOMS OF DIARRHEA
4 FL OZ (120 mL)
1 mg Loperamide Hydrochloride per 7.5 mLClose
- INGREDIENTS AND APPEARANCE
SUNMARK LOPERAMIDE HYDROCHLORIDE
loperamide hcl suspension
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49348-999 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 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 Color GREEN (opaque, viscous) Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49348-999-34 120 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091292 02/18/2014 Labeler - McKesson (177667227)