NDC 54973-3124 Defend Cold And Cough

Onion, Calcium Sulfide, Sodium Chloride, Phosphorus, Pulsatilla Vulgaris, Sulfur, And Goldenseal

NDC Product Code 54973-3124

NDC Code: 54973-3124

Proprietary Name: Defend Cold And Cough 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: Onion, Calcium Sulfide, Sodium Chloride, Phosphorus, Pulsatilla Vulgaris, Sulfur, And Goldenseal 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.

NDC Code Structure

  • 54973 - Hyland's

NDC 54973-3124-4

Package Description: 118 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Defend Cold And Cough with NDC 54973-3124 is a a human over the counter drug product labeled by Hyland's. The generic name of Defend Cold And Cough is onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Hyland's

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Defend Cold And Cough 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.

  • ONION 6 [hp_X]/mL
  • CALCIUM SULFIDE 12 [hp_X]/mL
  • SODIUM CHLORIDE 6 [hp_X]/mL
  • PHOSPHORUS 12 [hp_X]/mL
  • PULSATILLA VULGARIS 6 [hp_X]/mL
  • SULFUR 12 [hp_X]/mL
  • GOLDENSEAL 6 [hp_X]/mL

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.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • GLYCERIN (UNII: PDC6A3C0OX)

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: Hyland's
Labeler Code: 54973
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: 06-17-2011 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.

Defend Cold And Cough Product Label Images

Defend Cold And Cough 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

A persistent cough may be a sign of a serious condition.

There have been no reports of interactions between this product and ibuprofen or acetaminophen.


In case of emergency, contact a medical professional or poison control center immediately. Hyland's may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

Otc - Active Ingredient

Active ingredientsPurposeAllium Cepa 6X HPUSwatery, runny nose, cold, hacking coughHepar Sulph Calc 12X HPUScold, sneezingHydrastis 6X HPUSrattling/tickling cough, sinus congestion, dry/raw/sore throatNatrum Muriaticum 6X HPUSdry cough, sore throatPhosphorus 12X HPUShoarse/dry cough, nasal congestion, chest congestionPulsatilla 6X HPUSmoist cough, cold, nasal congestionSulphur 12X HPUSnasal congestion, chest congestion, sneezing, runny nose“HPUS” indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Uses

Temporarily relieves the symptoms of the common cold including nasal and chest congestion, runny nose, cough, sore throat and sneezing.

Otc - Pregnancy Or Breast Feeding

  • As with any drug, ask a doctor before use if pregnant or nursing. Consult a physician if:Symptoms persist for more than 7 days or worsenInflammation, fever or infection developsSymptoms are accompanied by high fever (101° F)Cough tends to recur or is accompanied by high fever, rash or persistent headache.

Otc - Keep Out Of Reach Of Children

Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or a poison control center immediately.

Otc - Do Not Use

Do not use this product for persistent or chronic cough such as occurs with asthma, smoking or emphysema or if cough is accompanied by excessive mucus, unless directed by a licensed health care professional.

Do not use if imprinted tamper band is broken or missing.

Sore Throat Warning

Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly.

Directions

  • Measure only with the dosing cup providedDo not use dosing cup with other productsOn dosing cup, tsp = teaspoon, mL = milliliteradults and children 12 years and over15 mL or 3 teaspoons up to 6 times per day (every 4 hours)children 6 years to under 12 years10 mL or 2 teaspoons up to 6 times per day (every 4 hours)children 2 years to under 6 years5 mL or 1 teaspoon up to 6 times per day (every 4 hours)

Inactive Ingredients

Citric Acid, Glycyrrhiza Extract, Purified Water, Sodium Benzoate, Vegetable Glycerine.

Otc - Purpose

Temporarily relieves the symptoms of the common cold including nasal and chest congestion, runny nose, cough, sore throat and sneezing.

* Please review the disclaimer below.