NDC 70797-308 Dr. Talbots Infant Daily Allergy Relief

Allium Cepa, Aralia Racemosa, Euphrasia Officinalis, Galphimia Glauca, Histaminum Hydrochloricum, Luffa Operculata, Pulsatilla, Solidago, Natrum Muriaticum

NDC Product Code 70797-308

NDC CODE: 70797-308

Proprietary Name: Dr. Talbots Infant Daily Allergy Relief 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: Allium Cepa, Aralia Racemosa, Euphrasia Officinalis, Galphimia Glauca, Histaminum Hydrochloricum, Luffa Operculata, Pulsatilla, Solidago, Natrum Muriaticum 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

  • 70797 - Talbot's Pharmaceuticals Family Products, Llc
    • 70797-308 - Dr. Talbots Infant Daily Allergy Relief

NDC 70797-308-01

Package Description: 1 BOTTLE in 1 CARTON > 118 mL in 1 BOTTLE (70797-308-04)

NDC Product Information

Dr. Talbots Infant Daily Allergy Relief with NDC 70797-308 is a a human over the counter drug product labeled by Talbot's Pharmaceuticals Family Products, Llc. The generic name of Dr. Talbots Infant Daily Allergy Relief is allium cepa, aralia racemosa, euphrasia officinalis, galphimia glauca, histaminum hydrochloricum, luffa operculata, pulsatilla, solidago, natrum muriaticum. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Talbot's Pharmaceuticals Family Products, Llc

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.

Dr. Talbots Infant Daily Allergy Relief 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.

  • LUFFA OPERCULATA FRUIT 12 [hp_X]/118mL
  • EUPHRASIA STRICTA 12 [hp_X]/118mL
  • GALPHIMIA GLAUCA FLOWERING TOP 12 [hp_X]/118mL
  • ARALIA RACEMOSA ROOT 12 [hp_X]/118mL
  • SOLIDAGO VIRGAUREA FLOWERING TOP 12 [hp_X]/118mL
  • SODIUM CHLORIDE 6 [hp_X]/118mL
  • ONION 12 [hp_X]/118mL
  • ANEMONE PULSATILLA 12 [hp_X]/118mL
  • HISTAMINE DIHYDROCHLORIDE 12 [hp_X]/118mL

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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • CONCORD GRAPE JUICE (UNII: F7039Q79LP)
  • WATER (UNII: 059QF0KO0R)

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: Talbot's Pharmaceuticals Family Products, Llc
Labeler Code: 70797
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: 06-01-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Dr. Talbots Infant Daily Allergy Relief Product Label Images

Dr. Talbots Infant Daily Allergy Relief 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

Otc - Active Ingredient

Active IngredientsAllium cepa 12X HPUSAralia racemosa 12X HPUSEuphrasia officinalis 12X HPUSGalphimia glauca 12X HPUSHistaminum hydrochloricum 12X HPUSLuffa operaculata 12X HPUSPulsatilla 12X HPUSSolidago 12X HPUSCell SaltsNatrum muriaticum 6X HPUS

Otc - Purpose

PurposeHay fever, watery eyesWatery irritating nasal dischargeEye irritation, watery eyesSneezing, runny noseHay fever, mild wheezingAcute rhinitisSinus painNasal dischargeSneezing, itchy eyes

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, consult your doctor before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. in case of overdoes (or accidental ingestion), get medical help or contact a Poison Control Center right away.
DO NOT USE IF SEAL UNDER CAP IS BROKEN OR MISSING.

Dosage & Administration

  • Shake before use, natural juice may settleMeasure only with the dosing syringe providedDo not use dosing syringe with other productsOn dosing syringe, weight is specific to productOn dosing syringe, ml = milliliter, lbs = pounds, kgs = kilogramsChildren under 6 months of age, consult a medical professional before using this product.For sudden onset of symptoms: Use every 15 minutes for up to 8 doses until symptoms relieved, then every 2 hours thereafter.Children 6 - 18 lbs or 3 - 8 kgs1.25 ml every 2 hours, reduce frequency when symptoms improveChildren 19 - 29 lbs or 9 - 13 kgs2.5 ml every 2 hours, reduce frequency when symptoms improveChildren 30 - 90 lbs or 14 - 41 kgs5 ml every 2 hours, reduce frequency when symptoms improve

Inactive Ingredient

Inactive ingredientsCitric acid, glycerin, grape juice, potassium sorbate, purified water

Otc - Questions

Questions or Comments?Call us at 1-855-366-7755 (U.S.A only)M-F 8am-5pm CST

Indications & Usage

UsesTemporarily relieves the symptoms associated with hay fever or other upper respiratory allergies, such assneezing

sinus pain

runny nose

watery eyes

mild wheezing

itchy nose and throat

Warnings

  • WarningsDo not use:to treat food allergiesfor persistent or chronic coughfor treating cough from asthma, smoking, or emphysemafor treating cough with excessive mucusA persistent cough may be a sign of a serious condition

* Please review the disclaimer below.