NDC 67091-333 Tussin Dm Nighttime Cough Maximum Strength

Dextromethorphan Hbr, Doxylamine Succinate

NDC Product Code 67091-333

NDC Code: 67091-333

Proprietary Name: Tussin Dm Nighttime Cough Maximum Strength Additional informationCallout TooltipWhat 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, Doxylamine Succinate Additional informationCallout TooltipWhat 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.


Code Structure
  • 67091 - Winco Foods, Llc
    • 67091-333 - Tussin Dm Nighttime Cough

NDC 67091-333-18

Package Description: 1 BOTTLE, PLASTIC in 1 BOX > 118 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Tussin Dm Nighttime Cough Maximum Strength with NDC 67091-333 is a a human over the counter drug product labeled by Winco Foods, Llc. The generic name of Tussin Dm Nighttime Cough Maximum Strength is dextromethorphan hbr, doxylamine succinate. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Winco Foods, 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 Additional informationCallout TooltipWhat 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.


Tussin Dm Nighttime Cough Maximum Strength Active Ingredient(s)

Additional informationCallout TooltipWhat 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 30 mg/20mL
  • DOXYLAMINE SUCCINATE 12.5 mg/20mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
  • MENTHOL (UNII: L7T10EIP3A)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Winco Foods, Llc
Labeler Code: 67091
FDA Application Number: part341 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 02-01-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Tussin Dm Nighttime Cough Maximum Strength Product Label Images

Tussin Dm Nighttime Cough Maximum Strength 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 Ingredients (In Each 20 Ml)

Dextromethorphan HBr 30 mgDoxylamine succinate 12.5 mg

Purposes

Cough suppressantAntihistamine

Uses

  • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • Runny nose
  • Sneezing
  • Itchy, watery eyes
  • Itching of the nose or throatcontrols the impulse to cough to help you sleep

Do Not Use

  • To sedate a child or to make a child sleepy
  • 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

  • Glaucoma
  • Trouble urinating due to an enlarged prostate gland
  • Cough that occurs with too much phlegm (mucus)
  • A breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema

Ask A Doctor Or Pharmacist Before Use If You Are

Taking sedatives or tranquilizers.

When Using This Product

  • Do not use more than directedmarked drowsiness may occur
  • Avoid alcoholic drinks
  • Alcohol, sedatives, and tranquilizers may increase drowsiness
  • Be careful when driving a motor vehicle or operating machinery
  • Excitability may occur especially in children

Stop Use And 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 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 (1-800-222-1222) right away.

Directions

  • This adult product is not intended for use in children under 12 years of age do not take more than 4 doses in any 24-hour period
  • Measure only with dosing cup provided. Do not use any other dosing device.
  • Keep dosing cup with product
  • ML = milliliter
  • Adults and children 12 years and over: 20 mL every 6 hours
  • Children under 12 years: do not use

Other Information

  • Each 20 mL contains: sodium 9 mLstore between 20-25°C (68-77°F). Do not refrigerate.

Inactive Ingredients

Anhydrous citric acid, carboxymethycellulose sodium, FD&C blue #1, FD&C red #40, flavors glycerin, high fructose corn syrup, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, xanthan gum

Package Label

WINCO FOODS Maximum Strength Nighttime Cough

* Please review the disclaimer below.

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