NDC 50991-121 Polytussin Dm

Dexbrompheniramine Maleate, Dextromethorphan Hbr, Phenylephrine Hcl

NDC Product Code 50991-121

NDC 50991-121-15

Package Description: 15 mL in 1 BOTTLE

NDC 50991-121-16

Package Description: 473 mL in 1 BOTTLE

NDC Product Information

Polytussin Dm with NDC 50991-121 is a a human over the counter drug product labeled by Poly Pharmaceuticals,. The generic name of Polytussin Dm is dexbrompheniramine maleate, dextromethorphan hbr, phenylephrine hcl. The product's dosage form is liquid and is administered via oral form.

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.

Polytussin Dm 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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)

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: Poly Pharmaceuticals,
Labeler Code: 50991
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: 10-20-2021 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.

Polytussin Dm Product Label Images

Polytussin Dm 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

Dexbrompheniramine Maleate 2 mg

Dextromethorphan Hydrobromide 15 mg

Phenylephrine Hydrochloride 7.5 mg

Purposes

AntihistamineAntitussive

Nasal Decongestant

Uses

Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

 runny nose
 sneezing

 itching of nose or throat

 itchy, watery eyes
 cough due to minor throat and bronchial irritation nasal congestion

 reduces swelling of nasal passages

Warnings

Do not exceed recommended dosage.

Do Not Use This Product

 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

 a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due toan enlarged prostate gland

 a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
 a cough that occurs with too much phlegm (mucus) heart disease

 high blood pressure

 thyroid disease

Ask A Doctor Or Pharmacist Before Use If

You are taking sedatives or tranquilizers.

When Using This Product

 excitability may occur, especially in children may cause marked drowsiness avoid alcoholic drinks

 alcohol, sedatives, and tranquilizers may increase the drowsiness effect
 be careful when driving a motor vehicle or operating machinery

Stop Use And Ask A Doctor If

 nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur, or is 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 Breastfeeding

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 exceed recommended dosageAdults and children 12 years of age and over1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls in 24Children 6 to under 12 years of age1/2 teaspoonful (2.5 mL) every 4 to 6 hours, not to exceed 3 teaspoonfuls in 24 hoursChildren under 6 years of ageConsult a doctor.

Other Information

Store at 59° - 86°F (15° - 30°C)

Inactive Ingredients

Anhydrous Citric Acid, Glycerin, Flavor, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate Dihydrate, Sodium Saccharin, Sorbitol Solution.

* Please review the disclaimer below.