Label: GOOD NEIGHBOR PHARMACY LOPERAMIDE HYDROCHLORIDE- loperamide hcl solution
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Contains inactivated NDC Code(s)
NDC Code(s): 17856-0545-1, 17856-0545-2 - Packager: ATLANTIC BIOLOGICALS CORP.
- This is a repackaged label.
- Source NDC Code(s): 46122-544
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 22, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each 7.5 mL)
- Purpose
- Use
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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
When using this product
tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.
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Directions
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- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
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- find right dose on chart. If possible, use weight to dose; otherwise use age.
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- shake well before using
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- use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
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- 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
- Inactive ingredients
- Questions or comments? DISTRIBUTED BY:ATLANTIC BIOLOGICALS CORP.20101 N.E 16TH PLACEMIAMI, FL 33179
- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
GOOD NEIGHBOR PHARMACY LOPERAMIDE HYDROCHLORIDE
loperamide hcl solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17856-0545(NDC:46122-544) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE 1 mg in 7.5 mL Inactive Ingredients Ingredient Name Strength 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) DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 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:17856-0545-2 72 in 1 BOX, UNIT-DOSE 01/22/2021 1 7.5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 2 NDC:17856-0545-1 50 in 1 BOX, UNIT-DOSE 01/22/2021 2 15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091292 08/13/2018 Labeler - ATLANTIC BIOLOGICALS CORP. (047437707) Establishment Name Address ID/FEI Business Operations ATLANTIC BIOLOGICALS CORP. 047437707 repack(17856-0545) , relabel(17856-0545)