NDC 50844-012 Cold And Flu Relief

Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl

NDC Product Code 50844-012

NDC Code: 50844-012

Proprietary Name: Cold And Flu Relief Additional informationCallout TooltipWhat 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: Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl Additional informationCallout TooltipWhat 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.


Code Structure
  • 50844 - L.n.k. International, Inc.
    • 50844-012 - Cold And Flu Relief

NDC 50844-012-45

Package Description: 177 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Cold And Flu Relief with NDC 50844-012 is a a human over the counter drug product labeled by L.n.k. International, Inc.. The generic name of Cold And Flu Relief is acetaminophen, dextromethorphan hbr, phenylephrine hcl. The product's dosage form is liquid and is administered via oral form.

Labeler Name: L.n.k. International, Inc.

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 Additional informationCallout TooltipWhat 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.


Cold And Flu Relief Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ACETAMINOPHEN 325 mg/15mL
  • DEXTROMETHORPHAN HYDROBROMIDE 10 mg/15mL
  • PHENYLEPHRINE HYDROCHLORIDE 5 mg/15mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
  • SODIUM METABISULFITE (UNII: 4VON5FNS3C)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SORBITOL (UNII: 506T60A25R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: L.n.k. International, Inc.
Labeler Code: 50844
FDA Application Number: part341 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 01-14-2019 Additional informationCallout TooltipWhat 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: 12-31-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Information for Patients

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.

Cold And Flu Relief Product Label Images

Cold And Flu Relief 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 15 Ml)

Acetaminophen 325 mgDextromethorphan HBr 10 mgPhenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducerCough suppressantNasal decongestant

Uses

  • Temporarily relieves common cold and flu symptoms:sore throatnasal congestionfeverheadacheminor aches and painscough due to minor throat and bronchial irritation

Warnings

  • Liver warning: This product contains acetaminophen. Severe liver damage may occur ifadult takes more than 4,000 mg of acetaminophen in 24 hourstaken with other drugs containing acetaminophenadult has 3 or more alcoholic drinks every day while using this productchild takes more than 5 doses in 24 hoursAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:skin reddeningblistersrashIf a skin reaction occurs, stop use and seek medical help right away.Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do Not Use

  • With any other drug containing acetaminophen (prescription or nonprescription). 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.if you have ever had an allergic reaction to this product or any of its ingredients

Ask A Doctor Before Use If The User Has

  • Difficulty in urination due to enlargement of the prostate glandcough that occurs with too much phlegm (mucus)liver diseasepersistent or chronic cough such as occurs with smoking, asthma, or emphysemaheart diseasediabetesthyroid diseasehigh blood pressure

Ask A Doctor Or Pharmacist Before Use If The User Is

Taking the blood thinning drug warfarin.

When Using This Product

Do not exceed recommended dosage.

Stop Use And Ask A Doctor If

  • Nervousness, dizziness, or sleeplessness occurfever gets worse or lasts more than 3 daysredness or swelling is presentnew symptoms occurpain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults)cough comes back or occurs with rash or headache that lasts. 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • Do not take more than directedmL = milliliter; FL OZ = fluid ounceuse only enclosed dosing cup designed for use with this product. Do not use any other dosing device.do not take more than 5 doses per 24 hoursadults and children 12 years and over30 mL every 4 hourschildren 6 to under 12 years15 mL every 4 hourschildren under 6 yearsdo not use

Other Information

  • Each 15 mL contains: sodium 13 mgstore at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)use by expiration date on package

Inactive Ingredients

Anhydrous citric acid, FD&C yellow #6, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sodium saccharin, sorbitol, sucralose

* Please review the disclaimer below.

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