NDC 0363-0444 Nighttime Daytime Cough

Dextromethorphan Hbr, Doxylamine Succinate

NDC Product Code 0363-0444

NDC CODE: 0363-0444

Proprietary Name: Nighttime Daytime Cough 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, 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

Color(s):
RED (C48326 - DARK RED)
ORANGE (C48331 - LIGHT)
Flavor(s):
CHERRY (C73375)
CITRUS (C73378 - BLEND)

NDC Code Structure

  • 0363 - Walgreen Company

NDC 0363-0444-02

Package Description: 1 KIT in 1 KIT * 355 mL in 1 BOTTLE (0363-0019-40) * 355 mL in 1 BOTTLE (0363-0500-40)

NDC Product Information

Nighttime Daytime Cough with NDC 0363-0444 is a a human over the counter drug product labeled by Walgreen Company. The generic name of Nighttime Daytime Cough is dextromethorphan hbr, doxylamine succinate. The product's dosage form is kit and is administered via form.

Labeler Name: Walgreen Company

Dosage Form: Kit - A packaged collection of related material.

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.

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.

  • ALCOHOL (UNII: 3K9958V90M)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • WATER (UNII: 059QF0KO0R)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Walgreen Company
Labeler Code: 0363
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: 02-25-2014 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]
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.

Nighttime Daytime Cough 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 30 Ml) - Nighttime Cough

Dextromethorphan HBr 30 mgDoxylamine succinate 12.5 mg

Purpose - Nighttime Cough

Cough suppressantAntihistamine

Uses – Nighttime Cough

  • Temporarily relieves cold symptoms: •cough due to minor throat and bronchial irritation •runny nose and sneezing

Do Not Use – Nighttime Cough

  • •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 – Nighttime Cough

  • •glaucoma •cough that occurs with too much phlegm (mucus) •a breathing problem such as emphysema or chronic bronchitis •persistent or chronic cough as occurs with smoking, asthma, or emphysema •trouble urinating due to an enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are – Nighttime Cough

Taking sedatives or tranquilizers

When Using This Product – Nighttime Cough

  • •excitability may occur, especially in children •may cause marked drowsiness •avoid alcoholic drinks •be careful when driving a motor vehicle or operating machinery •alcohol, sedatives, and tranquilizers may increase drowsiness

Stop Use And Ask A Doctor If – Nighttime Cough

  • Cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

If Pregnancy Or Breast-Feeding, - Nighttime Cough

Ask a health professional before use.

Keep Out Of Reach Of Children – Nighttime Cough

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions – Nighttime Cough

  • •take only as directed •only use the dose cup provided •do not exceed 4 doses per 24 hrsadults & children 12 yrs & over30 mL every 6 hrschildren 4 to under 12 yrsask a doctorchildren under 4 yrsdo not use

Other Information – Nighttime Cough

  • •each 30 mL contains: sodium 32 mg •store at 20°-25°C (68°-77°F)

Inactive Ingredients – Nighttime Cough

Alcohol, anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Active Ingredient (In Each 15 Ml) - Daytime Cough

Dextromethorphan HBr 15 mg

Purpose - Daytime Cough

Cough suppressant

Uses – Daytime Cough

Temporarily relieves cough due to minor throat and bronchial irritation associated with a cold

Do Not Use – Daytime Cough

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 – Daytime Cough

  • •cough that occurs with too much phlegm (mucus) •persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Stop Use And Ask A Doctor If – Daytime Cough

Cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

If Pregnant Or Breast-Feeding, - Daytime Cough

Ask a health professional before use.

Keep Out Of Reach Of Children. – Daytime Cough

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions – Daytime Cough

  • •take only as directed •only use the dose cup provided •do not exceed 4 doses per 24 hrsadults & children 12 yrs & over30 mL every 6-8 hrschildren 6 to under 12 yrs15 mL every 6-8 hrschildren 4 to under 6 yrsask a doctorchildren under 4 yrsdo not use

Other Information – Daytime Cough

  • •each 15 mL contains: sodium 13 mg •store at 20°-25°C (68°-77°F) •does not meet USP requirements for light resistant packaging

Inactive Ingredients – Daytime Cough

Anhydrous citric acid, D&C yellow #10, FD&C yellow #6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

* Please review the disclaimer below.