NDC 62558-002 Doctor Manzanilla Allergy And Decongestant Relief

Doctor Manzanilla Allergy And Decongestant Relief

NDC Product Code 62558-002

NDC CODE: 62558-002

Proprietary Name: Doctor Manzanilla Allergy And Decongestant 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: Doctor Manzanilla Allergy And Decongestant Relief 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

  • 62558 - Mid Valley Pharmaceuticals Llc
    • 62558-002 - Doctor Manzanilla Allergy And Decongestant Relief

NDC 62558-002-04

Package Description: 1 BOTTLE in 1 CARTON > 118 mL in 1 BOTTLE

NDC Product Information

Doctor Manzanilla Allergy And Decongestant Relief with NDC 62558-002 is a a human over the counter drug product labeled by Mid Valley Pharmaceuticals Llc. The generic name of Doctor Manzanilla Allergy And Decongestant Relief is doctor manzanilla allergy and decongestant relief. The product's dosage form is syrup and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1086720.

Dosage Form: Syrup - An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions.

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.

Doctor Manzanilla Allergy And Decongestant 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.


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)
  • EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • OREGANO (UNII: 0E5AT8T16U)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SORBITOL (UNII: 506T60A25R)
  • 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: Mid Valley Pharmaceuticals Llc
Labeler Code: 62558
FDA Application Number: part341 What 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: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 01-12-2017 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: 12-31-2021 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.

Doctor Manzanilla Allergy And Decongestant 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

Drug Facts:

ACTIVE INGREDIENTS (IN EACH 5ML)Diphenhydramine Hydrochloride 12.5mgPhenylephrine Hydrochloride 5mL

Purpose:

AntihistamineNasal Decongestant

Uses:

  • Temporarily relieves:runny nosesneezingitching of the nose or throatitchy, watery eyes due to hay fever or other upper respiratory allergies or allergic rhinitiscough associated with a coldthe cough reflex that causes coughingnasal congestionPromotes nasal and/or sinus drainagetemporarily relieves sinus congestion and pressure.

Warnings:

  • Warnings:Do not use - Do not exceed recommended dosage.If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor.If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug.If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.With any other product containing diphenhydramine, even one used on skin. If symptoms do not improve within seven days or are accompanied by fever, consult a doctor. Ask a doctor before use if you have:heart diseasehigh blood pressurethyroid diseasediabetesglaucomaa breathing problem such as emphysema or chronic bronchitistrouble urinating due an enlarged prostate glandcough that occurs that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or if cough is accompanied by excessive phlegm (mucus).Ask a doctor or pharmacistbefore use if you are taking sedatives or tranquilizers.When using this product:do not exceed recommended dosagemay cause excitability especially in childrenmay cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effectavoid alcoholic beverages while taking this productuse caution when driving a motor vehicle or operating machinery.Stop use and ask a doctor if:you get nervous, dizzy, or sleeplessness occurssymptoms do not improve within 7 days, tend to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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.

Directions:

Do not take more than 6 doses in 24 hours. Adults and children 12 years of age and over 2 teaspoonfuls (10mL) every 4 hours Children 6 to under 12 years of age 1 teaspoonfuls (5mL) every 4 hours Children under 6 years of age Consult a doctor

Other Information:

Store at controlled room temperature 15º - 30ºC (59º-86ºF). Each dose contains 10 mg sodium.

Inactive Ingredients:

Caramel Color, Oregano Extract, Citric Acid, Glycerin, Propylene Glycol, Sorbitol, Sucralose, Edetate Calcuim Disodium, Sodium Benzoate, Natural Chamomile Flavor, Natural Cherry Flavor, Purified Water.

Adverse Reactions:

In case of overdose, get medical help or contact a Poison Control Center right away.

Doctor Manzanilla Allergy Carton Label

Doctor Manzanilla Allergy Carton LabelDoctor ManzanillaALLERGY100%Natural ChamomileDoctor ManzanillaALLERGY &DECONGESTANT RELIEFALIVIO DE ALERGIA &DESCONGESTIONANTE4 FL OZ. (118 ml)Diphenhydramine HCl(Antihistamine)Phenylephrine HCl(Nasal Decongestant)100% Manzanilla NaturalPARA EL GUSTO DE TU TRANQUIL!IDADAlivia!AlergiasCongestion NasalIrritacion de GargantaEstornudoOjos llorosospor fiebre de henoAntistaminicoDoctor Manzanilla100% Natural ChamomileFOR A GREAT SOOTHING TASTERelieves!AllergyNasal DecongestantItchy ThroatSneezingItching watery eyesAntihistamineDoctor ManzanillaDistributed by: Midvalley PharmaceuticalsRaymondville, TX 78580Bar Code7 62558 00204 1

Doctor Manzanilla Allergy Container Label

Doctor Manzanilla Allergy Container Label100% Natural ChamomileDoctor ManzanillaALLERGY &DECONGESTANT RELIEFALIVIO DE ALERGIA & DESCONGESTIONANTE4 FL OZ. (118 mL)Distributed by: Midvalley PharmaceuticalsRaymondville, TX 78580Bar Code7 62558 00204 1Container Label

* Please review the disclaimer below.