NDC 70154-112 Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride

Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride

NDC Product Code 70154-112

NDC Code: 70154-112

Proprietary Name: Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride 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 Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride 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

  • 70154 - Monarch Pcm, Llc.
    • 70154-112 - Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride

NDC 70154-112-08

Package Description: 240 mL in 1 BOTTLE

NDC Product Information

Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride with NDC 70154-112 is a a human over the counter drug product labeled by Monarch Pcm, Llc.. The generic name of Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride is dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Monarch Pcm, 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.

Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride 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.

  • DEXTROMETHORPHAN HYDROBROMIDE 18 mg/15mL
  • GUAIFENESIN 200 mg/15mL
  • PHENYLEPHRINE HYDROCHLORIDE 10 mg/15mL

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.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SORBITOL (UNII: 506T60A25R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)

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: Monarch Pcm, Llc.
Labeler Code: 70154
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: 08-19-2019 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.

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.

Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride Product Label Images

Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride 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

Dextromethorphan HBrGuaifenesin

Phenylephrine HCl
70154-112-088 fl. Oz. (240 mL)

Active Ingredients (In Each 15 Ml (Tbsp))

Dextromethorphan HBr 18 mgGuaifenesin 200 mgPhenylephrine HCl 10 mg

Uses

  • Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • Temporarily relieves:○ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants○ the intensity of coughing○ the impulse to cough to help you get to sleep○ nasal congestion due to a cold

Warnings

Do not use 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.

Ask A Doctor Before Use If You Have

  • Heart disease
  • High blood pressure
  • Thyroid disease
  • Diabetes
  • A cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
  • A cough that occurs with too much phlegm (mucus)
  • Difficulty in urination due to enlargement of the prostate gland

When Using This Product

Do not use more than directed

Stop Use And Ask A Doctor If:

■ nervousness, dizziness, or sleeplessness occurs

■ symptoms do not improve within 7 days, tend to recur, or

are accompanied by a fever, rash or persistent headache.

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

■ new symptoms occur

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 any 24-hour period
  • Use enclosed dosage cup or tablespoon (TBSP)
  • Dose as follows or as directed by a doctorAdults and children 12 years of age and over:15 mL (1 TBSP) every 4 hours, not to exceed 90 mL (6 TBSP) iper 24 hoursChildren 6 to under 12 years of age:7.5 mL (1/2 TBSP) every 4 hours, not to exceed 45 mL (3 TBSP) per 24 hoursChildren under 6 years of age:Consult a doctor.

Other Information

■ this packaging is child-resistant.

■ each 15 mL (1 TBSP) contains:Sodium
8 mg
■ store at room temperature 15-30°C (59-86°F)

Inactive Ingredients

Citric acid anhydrous, glycerin, masking agent, propylene glycol, purified water, raspberry flavor, sodium benzoate, sodium citrate dihydrate, sodium saccharin, sorbitol

* Please review the disclaimer below.