NDC 69842-657 Daytime And Nighttime Cough And Chest Congestion Childrens

Dextromethorphan Hbr, Guaifenesin, Chlorpheniramine Maleate

NDC Product Code 69842-657

NDC Code: 69842-657

Proprietary Name: Daytime And Nighttime Cough And Chest Congestion Childrens 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, Guaifenesin, Chlorpheniramine Maleate 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.

NDC Code Structure

  • 69842 - Cvs Pharmacy
    • 69842-657 - Daytime And Nighttime Cough And Chest Congestion

NDC 69842-657-08

Package Description: 1 KIT in 1 KIT * 118 mL in 1 BOTTLE * 118 mL in 1 BOTTLE

NDC Product Information

Daytime And Nighttime Cough And Chest Congestion Childrens with NDC 69842-657 is a a human over the counter drug product labeled by Cvs Pharmacy. The generic name of Daytime And Nighttime Cough And Chest Congestion Childrens is dextromethorphan hbr, guaifenesin, chlorpheniramine maleate. The product's dosage form is kit and is administered via form.

Labeler Name: Cvs Pharmacy

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.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • POTASSIUM CITRATE (UNII: EE90ONI6FF)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SORBITOL (UNII: 506T60A25R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • 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)

Product Labeler Information

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

Labeler Name: Cvs Pharmacy
Labeler Code: 69842
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: 02-19-2019 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.

Daytime And Nighttime Cough And Chest Congestion Childrens Product Label Images

Daytime And Nighttime Cough And Chest Congestion 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 Day Time (In Each 5 Ml)

Dextromethorphan HBr USP 5 mgGuaifenesin. USP 100 mg

Active Ingredients For Nighttime (In Each 10 Ml)

Chlorpheniramine maleate, USP 2 mgDextromethorphan HBr USP 15 mg

Purposes For Day Time

Cough suppressantExpectorant

Purpose For Night Time

AntihistamineCough suppressant

Uses

  • DAYTIME •temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold •helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubesNIGHTTIME •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

  • DAYTIME •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.NIGHTTIME •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

  • DAYTIME •cough that occurs with too much phlegm (mucus) •cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysemaNIGHTTIME •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

NIGHTTIMEtaking sedatives or tranquilizers.

When Using This Product

  • NIGHTTIME •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

  • DAYTIME •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.NIGHTTIME •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,

DAYTIMEask a health professional before use.NIGHTTIMEask a health professional before use

Keep Out Of Reach Of Children.

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

Directions

  • DAYTIME •measure only with dosing cup provided. •keep dosing cup with product •mL= milliliter •do not take more than 6 doses in any 24-hour periodagedoseChildren under 4 yearsDo not useChildren 4 to under 6 years5 mL every 4 hoursChildren 6 to under 12 years10 mL every 4 hoursAdults and children 12 years and older20 mL every 4 hoursNIGHTTIME •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

  • DAYTIME •each 5 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 NIGHTTIME •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

Inactive ingredients for Day Time anhydrous citric acid, edetate disodium, FD &C Blue # 1, FD&C Red # 40, natural and artificial flavors, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gumInactive ingredients for Night Time anhydrous citric acid, FD&C Red # 40, natural and artificial flavors, potassium sorbate, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose

* Please review the disclaimer below.

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