NDC 54973-3400 4 Kids Cold And Cough Daytime

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

NDC Product Code 54973-3400

NDC Code: 54973-3400

Proprietary Name: 4 Kids Cold And Cough Daytime 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 54973-3400-1

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 148 mL in 1 BOTTLE, PLASTIC

NDC Product Information

4 Kids Cold And Cough Daytime with NDC 54973-3400 is a a human over the counter drug product labeled by Hyland's. The generic name of 4 Kids Cold And Cough Daytime 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.

4 Kids Cold And Cough Daytime 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
  • SULFUR 12 [hp_X]/mL
  • PHOSPHORUS 12 [hp_X]/mL
  • ANEMONE PULSATILLA 6 [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.

  • WATER (UNII: 059QF0KO0R)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
  • 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: 08-01-2008 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.

4 Kids Cold And Cough Daytime Product Label Images

4 Kids Cold And Cough Daytime 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 Ingredients

Allium Cepa 6X HPUSHepar Sulph Calc 12X HPUSHydrastis 6X HPUSNatrum Muriaticum 6X HPUSPhosphorus 12X HPUSPulsatilla 6X HPUSSulphur 12X HPUS"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Purpose

Allium Cepa 6X HPUS..........................watery/runny nose, cold, hacking cough, painful throatHepar Sulph Calc 12X HPUS................cold, sneezingHydrastis 6X HPUS................................rattling/tickling cough, sinus congestion, dry/raw/sore throatNatrum Muriaticum 6X HPUS................dry cough, sore throatPhosphorus 12X HPUS.........................hoarse/dry cough, nasal congestion, chest congestionPulsatilla 6X HPUS................................moist cough, cold, nasal congestionSulphur 12X HPUS................................chest congestion, nasal congestion, sneezing, runny nose

Uses

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

Otc - Pregnancy Or Breast Feeding

As with any drug, ask a doctor before use if pregnant or breast-feeding.

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

Keep This And All Medications Out Of The Reach Of Children

In case of accidental overdose, contact a medical professional or Poison Control Center immediately.

Do Not Use This Product

For persistent or chronic cough such as asthma, smoking or emphysema or if cough is accompanied by excessive mucus, unless directed by a licensed medical professional.

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.

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.

Directions

  • Measure only with the dosing cup providedDo not use dosing cup with other productsOn dosing cup, mL = milliliter, tsp = teaspoonChildren 2 years tounder 6 years5 mL or 1 teaspoon up to 6times per day (every 4 hours)Children 6 years tounder 12 years10 mL or 2 teaspoons up to 6times per day (every 4 hours)Adults and children12 years and over15 mL or 3 teaspoons up to 6times per day (every 4 hours)

Inactive Ingredients

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

* Please review the disclaimer below.