NDC 0295-5307 Safetussin PM

Dextromethorphan Doxylamine Succinate

NDC Product Code 0295-5307

NDC CODE: 0295-5307

Proprietary Name: Safetussin PM 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 Doxylamine Succinate 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):
MINT (C73404)

NDC Code Structure

  • 0295 - Denison Pharmaceuticals, Llc.

NDC 0295-5307-17

Package Description: 1 BOTTLE in 1 CARTON > 120 mL in 1 BOTTLE

NDC Product Information

Safetussin PM with NDC 0295-5307 is a a human over the counter drug product labeled by Denison Pharmaceuticals, Llc.. The generic name of Safetussin PM is dextromethorphan doxylamine succinate. 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: 1115329.

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.

Safetussin PM 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.

  • ASPARTAME (UNII: Z0H242BBR1)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • MINT (UNII: FV98Z8GITP)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • 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: Denison Pharmaceuticals, Llc.
Labeler Code: 0295
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: 01-01-2017 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.

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]
Doxylamine

Doxylamine is pronounced as (dox il' a meen)
Why is doxylamine medication prescribed?
Doxylamine is used in the short-term treatment of insomnia (difficulty falling asleep or staying asleep). Doxylamine is also used in combination with decongestants and ot...
[Read More]

* Please review the disclaimer below.

Safetussin PM Product Label Images

Safetussin PM 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 Ingredient

Active ingredients (in each 5ml tsp)PurposeDextromethorphan HBr,USP 7.5 mgCough Suppressant Doxylamine Succinate, USP 3.125 mg Expectorant

Uses

Cough SuppressantAntihistamine

Keep Out Of Reach Of Children

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

Indications & Usage

  • Temporarily relieves coughgh • runny nose and sneezing

Dosage & Administration

Agedoseadults and children12 years and over4 teaspoonsevery 6 hourschildren 4 to 12 yearsask a doctorchildren under 4 yearsdo not use

Inactive Ingredient

Aspartame,benzoic acid,citric acid,glycerin,menthol,methylparaben,natural peppermint flavor,propylene glycol,propylparaben purified water

Warnings

Do not useif 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 you use if you have:Asthmaemphysemaglaucomaexcessive phlem (mucus)breathing problemchronic bronchitispersisten or chronic coughcough associated with smokingtrouble urinating do to enlarged prostate glanda sodium restricted diet

Ask Doctor/Pharmacist

If you are taking sedatives or tranquilizers.

When Using

  • Do not use more than directedexcitability may occur, specially in childrenmarked drowsiness may occuravoid alcoholic drinksbe careful when driingbe careful when driving a motor vehicle or operating machineryalcohol, sedatives and tranquilizers may increase drowsiness

Stop Use

Ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of serious conditions.

Other Information

  • Protect from excessive heat and freezing. Store at 15° - 30° C (59° - 86° F)Phenylketonurics: each teaspoon contains phenylalanine 4.2 mgSafe this package for complete information

* Please review the disclaimer below.