NDC 0363-7560 Walgreens Childrens

Nighttime Cough

NDC Product Code 0363-7560

NDC Product Information

Walgreens Childrens with NDC 0363-7560 is a a human over the counter drug product labeled by Walgreens Co.. The generic name of Walgreens Childrens is nighttime cough. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Walgreens Co.

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.

Walgreens Childrens 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.

  • CHLORPHENIRAMINE MALEATE 2 mg/10mL
  • DEXTROMETHORPHAN HYDROBROMIDE 15 mg/10mL

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)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • POTASSIUM CITRATE (UNII: EE90ONI6FF)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SORBITOL (UNII: 506T60A25R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

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: Walgreens Co.
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: 07-16-2019 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.

Walgreens Childrens Product Label Images

Walgreens Childrens 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 10 Ml)

Chlorpheniramine maleate, USP 2 mgDextromethorphan HBr USP 15 mg

Purpose

AntihistamineCough suppressant

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▪itching of the nose or throat  ▪itchy, watery eyes

Do Not Us

  • ▪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

  • ▪trouble urinating due to an enlarges prostate gland▪glaucoma ▪a 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 directed.▪marked 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 last 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

  • ▪measure only with dosing cup provided.▪keep dosing cup with product ▪mL= milliliter ▪do not take more than 4 doses in any 24-hour periodagedoseChildren under 6 yearsDo not useChildren 6 to under 12 years10 mL every 6 hoursAdults and children 12 years and older20 mL every 6 hours

Other Information

  • ▪each 10 mL contains: sodium 3 mg •store at room temperature. Do not refrigerate •contain low sodium •do not use if printed seal under cap is torn or missing

Inactive Ingredients

Anhydrous citric acid, FD&C Red # 40, flavor, potassium sorbate, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose

* Please review the disclaimer below.

Previous Code
0363-7550
Next Code
0363-7610