NDC 68163-118 Zinc Cold Therapy Citrus Flavor

Zinc Gluconate

NDC Product Code 68163-118

NDC Code: 68163-118

Proprietary Name: Zinc Cold Therapy Citrus Flavor What 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: Zinc Gluconate What 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.

Product Characteristics

Color(s):
ORANGE (C48331)
Shape: ROUND (C48348)
Size(s):
16 MM
Imprint(s):
RP118
Score: 1
Flavor(s):
CITRUS (C73378)

NDC Code Structure

  • 68163 - Raritan Pharmaceuticals Inc
    • 68163-118 - Zinc Cold Therapy

NDC 68163-118-25

Package Description: 25 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC

NDC Product Information

Zinc Cold Therapy Citrus Flavor with NDC 68163-118 is a a human over the counter drug product labeled by Raritan Pharmaceuticals Inc. The generic name of Zinc Cold Therapy Citrus Flavor is zinc gluconate. The product's dosage form is tablet, chewable and is administered via oral form.

Labeler Name: Raritan Pharmaceuticals Inc

Dosage Form: Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.

Product Type: Human Otc Drug What 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.

Zinc Cold Therapy Citrus Flavor Active Ingredient(s)

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

  • ZINC GLUCONATE 1 [hp_X]/1

Inactive Ingredient(s)

About 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.

  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • SORBITOL (UNII: 506T60A25R)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

Administration Route(s)

What 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

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Raritan Pharmaceuticals Inc
Labeler Code: 68163
Marketing Category: UNAPPROVED HOMEOPATHIC - What 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: 04-19-2019 What 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 What 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 What 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.

Zinc Cold Therapy Citrus Flavor Product Label Images

Zinc Cold Therapy Citrus Flavor 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

Other

Drug Facts

Active Ingredient (In Each Tablet

Zincum Gluconicum 1x (11mg Zinc)

Purpose

Cold Remedy

Uses

  • •may help reduce duration and severity of cold symptoms •sore throat •stuffy nose •sneezing •coughing This product was formulated to help reduce the duration and severity of cold symptoms and was not formulated to be effective for flu or allergies.

Otc - Ask Doctor

  • •a sensitivity to zinc or are allergic to zinc •are taking minocycline, doxycycline, tetracycline or are on Coumadin therapy, zinc treatment may inhibit the absorption of these medicines.

Otc - Stop Use

Stop use and ask a doctor if symptoms persist beyond 7 days.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222

Directions

  • •For best results, use at the first sign of a cold and continue to use as directed •adults and children 12 years of age and older: •chew one tablet completely at the onset of symptoms. Do not swallow tablets whole. •repeat every 3 hours until symptoms are gone •to avoid minor stomach upset, do not take on an empty stomach. •do not eat or drink for 15 minutes after use. Do not eat or drink citrus fruits or juices for 30 minutes before or after use. Otherwise, drink plenty of fluids •recommended daily dose is 6 tablets for adults and 4 tablets for ages 12 through 17 •Children under 12 years of age: Consult a doctor before use.

Other Information

  • •do not take zinc tablets on an empty stomach to avoid possible minor stomach upset. •store at room temperature

Inactive Ingredients

Ascorbic acid, crospovidone, FD&C Yellow No. 6, flavor, magnesium stearate, sorbitol, starch, sucralose

* Please review the disclaimer below.

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