NDC 70677-0011 Daytime Cold And Flu

Product Information

What is NDC 70677-0011?

The NDC code 70677-0011 is assigned by the FDA to the product Daytime Cold And Flu which is product labeled by Mckesson. The product's dosage form is and is administered via form. The product is distributed in a single package with assigned NDC code 70677-0011-1 24 carton in 1 blister pack / 1 capsule, liquid filled in 1 carton. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code70677-0011
Proprietary Name 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.		Daytime Cold And Flu
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Mckesson
Labeler Code70677
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		11-25-2016
Listing Expiration Date 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.		12-31-2017
Exclude Flag 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". 		I
NDC Code Structure

What are the uses for Daytime Cold And Flu?


Product Characteristics

Color(s)ORANGE (C48331)
ShapeCAPSULE (C48336)
Size(s)22 MM
Imprint(s)512
Score1

Product Packages

NDC Code 70677-0011-1

Package Description: 24 CARTON in 1 BLISTER PACK / 1 CAPSULE, LIQUID FILLED in 1 CARTON

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

Daytime Cold And Flu Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1086997 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule
  • RxCUI: 1086997 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule
  • RxCUI: 1086997 - APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule

Daytime Cold And Flu Inactive Ingredients UNII Codes

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.

* Please review the disclaimer below.

Patient Education

Acetaminophen

Acetaminophen is pronounced as (a set a mee' noe fen)

Why is acetaminophen medication prescribed?
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to va...
[Read More]
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]
Phenylephrine

Phenylephrine is pronounced as (fen il ef' rin)
Why is phenylephrine medication prescribed?
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will ...
[Read More]

* Please review the disclaimer below.

Daytime Cold And Flu Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Active Ingredient



(in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg


Purpose



pain reliever

Cough Suppressant

Nasal decongestant


Uses



pain reliever, cough suppressant and Nasal decongestant


Warnings



Warnings Failure to follow these warnings could result in serious consequences.

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4 doses in 24 hours which is maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

    • do not use:

    • with any other drug containing acetaminophen (prescription or not prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • 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

      • liver disease
      • Heart disease
      • Thyroid disease
      • Diabetes
      • High blood pressure
      • Trouble urinating due to enlarged prostate gland

        • ask your doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product, do not use more than directed.

        • Stop use and ask a doctor if:

          • Redness or swelling is present
          • You get nervous, dizzy or sleepless
          • Fever gets worse or lasts more than 3 days
          • New symptoms occur
          • Symptoms do not get better within 7 days or are accompanied by a fever

Keep Out Of Reach Of Children.



If pregnant or breast-feeding, ask a health professional before use.

Overdose warning: Taking more than recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Tamper evident: this package is safety sealed and child resistant. Use only if blisters are intact. If difficult to open use scissors.


Direction



  • do not exceed 4 doses per 24 hours
  • take only as directed – see overdose warning
  • Adults and children 12 years and over: 2 softgels with water every 4 hours
  • Children under 4 to under 12 years: ask a doctor
  • Children under 4 years: do not use

Other Information



  • store at room temperature

Inactive Ingredients



FD&C Red No.40, FD&C Yellow No. 6, Gelatin, Glycerin, Poyethylene Glycol, Povidone, Propylene Glycol, Purified Water, Sorbitol Special, Titanium dioxide


Questions Or Comments



Call toll free 1-855-314-1850


Package Label.Principal Display Panel



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NDC: 70677-0011-1   24 liquid caps


* Please review the disclaimer below.