NDC 17856-0111 Good Neighbor Pharmacy Loperamide Hydrochloride

Loperamide Hcl

NDC Product Code 17856-0111

NDC Code: 17856-0111

Proprietary Name: Good Neighbor Pharmacy Loperamide Hydrochloride Additional informationCallout TooltipWhat is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Loperamide Hcl Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Code Structure
  • 17856 - Atlantic Biologicals Corp.
    • 17856-0111 - Good Neighbor Pharmacy Loperamide Hydrochloride

NDC 17856-0111-2

Package Description: 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE > 10 mL in 1 CUP, UNIT-DOSE

NDC 17856-0111-3

Package Description: 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE > 5 mL in 1 CUP, UNIT-DOSE

NDC 17856-0111-4

Package Description: 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE > 15 mL in 1 CUP, UNIT-DOSE

NDC 17856-0111-5

Package Description: 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE > 7.5 mL in 1 CUP, UNIT-DOSE

NDC Product Information

Good Neighbor Pharmacy Loperamide Hydrochloride with NDC 17856-0111 is a a human over the counter drug product labeled by Atlantic Biologicals Corp.. The generic name of Good Neighbor Pharmacy Loperamide Hydrochloride is loperamide hcl. The product's dosage form is suspension and is administered via oral form.

Labeler Name: Atlantic Biologicals Corp.

Dosage Form: Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.


Good Neighbor Pharmacy Loperamide Hydrochloride Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)

Administration Route(s)

Additional informationCallout TooltipWhat are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Atlantic Biologicals Corp.
Labeler Code: 17856
FDA Application Number: ANDA091292 Additional informationCallout TooltipWhat is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. Additional informationCallout TooltipWhat is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-26-2019 Additional informationCallout TooltipWhat is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 Additional informationCallout TooltipWhat is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N Additional informationCallout TooltipWhat is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Good Neighbor Pharmacy Loperamide Hydrochloride Product Label Images

Good Neighbor Pharmacy Loperamide Hydrochloride Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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 productadults and children 12 years and over30 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 hourschildren 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 hourschildren 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 hourschildren 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

Distributed By:Atlantic Biologicals Corp.20101 N.E 16Th Placemiami,Fl 33179

1-800-719-9260

* Please review the disclaimer below.

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