NDC 53163-106 Igualtuss

Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl

NDC Product Code 53163-106

NDC CODE: 53163-106

Proprietary Name: Igualtuss 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: Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl 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

Flavor(s):
CHERRY (C73375 - CHERRY FLAVOR)

NDC Code Structure

  • 53163 - Alternative Pharmacal Corporation

NDC 53163-106-16

Package Description: 473 mL in 1 BOTTLE

NDC Product Information

Igualtuss with NDC 53163-106 is a a human over the counter drug product labeled by Alternative Pharmacal Corporation. The generic name of Igualtuss is dextromethorphan hbr, guaifenesin, phenylephrine hcl. The product's dosage form is liquid and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 880359.

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.

Igualtuss 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.

  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • MENTHOL (UNII: L7T10EIP3A)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

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: Alternative Pharmacal Corporation
Labeler Code: 53163
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: 03-01-2014 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.

Information for Patients

Dextromethorphan

Dextromethorphan is pronounced as (dex troe meth or' fan)

Why is dextromethorphan medication prescribed?
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat th...
[Read More]
Guaifenesin

Guaifenesin is pronounced as (gwye fen' e sin)
Why is guaifenesin medication prescribed?
Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a cla...
[Read More]
Phenylephrine

Phenylephrine is pronounced as (fen il ef' rin)
Why is phenylephrine medication prescribed?
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will ...
[Read More]

* Please review the disclaimer below.

Igualtuss Product Label Images

Igualtuss 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 Ingredients (in each 5 mL tsp.)              PurposeDextromethorphan HBr ............... 28 mg ................ Cough SuppressantGuaifenesin .............................. 388 mg ................ ExpectorantPhenylephrine HCl ..................... 10 mg ................... Nasal Decongestant

Otc - Purpose

Purpose  Cough SuppressantExpectorantNasal Decongestant

Warnings

  • WarningsDo not exceed recommended dosageA persistent cough may be a sign of a serious condition. If cough persists for more than a week, tends to reccur or is accompanied by a fever, rash or persistent headache, consult a doctorIf nervousness, dizziness or sleeplessness occur, discontinue use and consult a doctorIf symptoms do not improve within 7 days or are accompanied by fever, consult a doctorWhen using this product, do not exceed recommended dosage

Otc - Do Not Use

  • Do not use For persistent cough such as occurs with smoking, asthma, chronic bronchitis, emphysema or where cough is accompanied by excessive phlegm (mucus), unless directed by a doctorIf you have a chronic pulmonary disease or shortness of breath, children who are taking other drugs, unless directed by doctorif 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 you are taking a prescription drug that contains an MAOI; ask your doctor or pharmacist before taking this productIf you haveheart diseasehigh blood pressurethyroid diseasediabetesdifficulty in urination due to the enlargment of the prostate gland unless directed by a doctor.

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.

Indications & Usage

  • Useshelps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucustemporarily relieves nasal congestion and cough due to minor throat and bronchial irritation ocurring with the common cold or inhaled irritants.

Dosage & Administration

Directions  Do not exceed more than 6 doses in any 24-hour periodAdults and children 12 years of age and over           take 1 teaspoonful (5 mL) every 4 hoursChildren 6 to under 12 years of age                          take 1/2 teaspoonful (2.5 mL) every 4 hoursChildren under 6 years of age                                   ask a doctor

Inactive Ingredient

Inactive ingredients: Citric acid, FD&C Yellow #6, flavor, menthol, methylparaben, polyethylene glycol, propylparaben, purified water, sodium citrate, glycerine and sucralose

Otc - Questions

Questions or comments? 1-786-507-1566

* Please review the disclaimer below.