NDC 69842-938 Daytime And Nighttime Sinus Congestion PE

Diphenhydramine Hcl, Phenylephrine Hcl

NDC Product Code 69842-938

NDC Code: 69842-938

Proprietary Name: Daytime And Nighttime Sinus Congestion PE 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: Diphenhydramine Hcl, Phenylephrine Hcl 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
    • 69842-938 - Daytime And Nighttime Sinus Congestion

NDC 69842-938-09

Package Description: 1 KIT in 1 PACKAGE, COMBINATION * 8 TABLET, FILM COATED in 1 BLISTER PACK * 12 TABLET, FILM COATED in 1 BLISTER PACK

NDC Product Information

Daytime And Nighttime Sinus Congestion PE with NDC 69842-938 is a a human over the counter drug product labeled by Cvs Pharmacy. The generic name of Daytime And Nighttime Sinus Congestion PE is diphenhydramine hcl, phenylephrine hcl. 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.

  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • DEXTROSE MONOHYDRATE (UNII: LX22YL083G)
  • DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
  • TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
  • FD&C BLUE NO. 1--ALUMINUM LAKE (UNII: J9EQA3S2JM)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYDEXTROSE (UNII: VH2XOU12IE)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TRIACETIN (UNII: XHX3C3X673)

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: 06-10-2019 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 Sinus Congestion PE Product Label Images

Daytime And Nighttime Sinus Congestion PE 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 (In Each Tablet) (Sinus Day)

Phenylephrine HCl 10 mg

Purpose

Nasal decongestant

AntihistamineNasal decongestant

Active Ingredients (In Each Tablet) (Sinus Night)

Diphenhydramine HCl 25 mgPhenylephrine HCl 10 mg

Uses

  • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:nasal congestion sneezing (Nighttime only)runny nose (Nighttime only)itchy, watery eyes (Nighttime only)itching of the nose or throat (Nighttime only)temporarily relieves these symptoms due to the common cold:nasal congestion sneezing (Nighttime only)runny nose (Nighttime only)temporarily relieves sinus congestion and pressure

Do Not Use

  • 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.with any other product containing diphenhydramine, even one used on skin (Nighttime only)

Ask A Doctor Before Use If You Have

  • Heart disease diabetesthyroid diseasehigh blood pressuredifficulty in urination due to enlargement of the prostate glanda breathing problem such as emphysema or chronic bronchitis (Nighttime only)glaucoma (Nighttime only)

Ask A Doctor Or Pharmacist Before Use If You Are

Taking sedatives or tranquilizers. (Nighttime only)

When Using This Product

  • Do not exceed recommended dosageexcitability may occur, especially in children (Nighttime only)marked drowsiness may occur (Nighttime only)alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)avoid alcoholic beverages (Nighttime only)use caution when driving a motor vehicle or operating machinery (Nighttime only)

Stop Use And Ask A Doctor If

  • Symptoms do not improve within 7 days or occur with fevernervousness, dizziness, or sleeplessness occur

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.If taking NIGHTTIME and DAYTIME products, carefully readeach section to ensure correct dosing. Do not take DAY & NIGHT at the same time.

Directions

  • Adults and children 12 years and overtake 1 tablet every 4 hoursdo not take more than 6 tablets in 24 hourschildren under 12 years: ask a doctor

Other Information

  • Each tablet contains: calcium 25 mg(Nighttime only)TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKENstore at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)see end flap for expiration date and lot number

Inactive Ingredients (Daytime Only)

Croscarmellose sodium, dextrose monohydrate, dibasic calcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide

Inactive Ingredients (Nighttime Only)

Croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silicon dioxide, stearic acid, titanium dioxide, triacetin

* Please review the disclaimer below.

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