NDC 44237-044 Novexcold

Acetaminophen, Pheniramine Maleate, Phenylephrine Hcl

NDC Product Code 44237-044

NDC Product Information

Novexcold with NDC 44237-044 is a a human over the counter drug product labeled by Herbion Pakistan (pvt.) Ltd. The generic name of Novexcold is acetaminophen, pheniramine maleate, phenylephrine hcl. The product's dosage form is powder, for solution and is administered via oral form.

Labeler Name: Herbion Pakistan (pvt.) Ltd

Dosage Form: Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.

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.

Novexcold 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.

  • ACETAMINOPHEN 650 mg/22g
  • PHENIRAMINE MALEATE 20 mg/22g
  • PHENYLEPHRINE HYDROCHLORIDE 10 mg/22g

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.

  • SUCROSE (UNII: C151H8M554)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • CALCIUM PHOSPHATE, UNSPECIFIED FORM (UNII: 97Z1WI3NDX)
  • MALIC ACID (UNII: 817L1N4CKP)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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.
  • 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: Herbion Pakistan (pvt.) Ltd
Labeler Code: 44237
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: 03-25-2020 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: 12-31-2021 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.

Novexcold Product Label Images

Novexcold 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

Otc - Active Ingredient

Active ingredient (in each packet)Acetaminophen, 650 mgPheniramine maleate, 20 mgPhenylephrine HCl, 10 mg

Otc - Purpose

PurposesPain reliever / fever reducerAntihistamineNasal decongestant

Indications & Usage

Uses• temporarily relieves these symptoms due to a cold:• minor aches and pains • minor sore throat pain • headache • nasal and sinus congestion • runny nose • sneezing • itchy nose or throat • itchy, watery eyes due to hay fever • temporarily reduces fever

Warnings

WarningsLiver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 4,000 mg of acetaminophen in 24 hours • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this productAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:• skin reddening • blisters • rashIf 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.

Otc - Ask Doctor

Ask a doctor before use if you have• liver disease • heart disease • high blood pressure • thyroid disease • diabetes • glaucoma • trouble urinating due to an enlarged prostate gland • a breathing problem such as emphysema, or chronic bronchitis • a sodium-restricted dietAsk a doctor or pharmacist before use if you are• taking sedatives or tranquilizers • taking the blood thinning drug warfarinWhen using this product• do not exceed recommended dosage•avoid alcoholic drinks•may cause drowsiness• alcohol, sedatives, and tranquilizers may increase drowsiness• be careful when driving a motor vehicle or operating machinery• excitability may occur, especially in childrenStop use and ask a doctor if• nervousness, dizziness, or sleeplessness occurs • pain or nasal congestion gets worse or lasts more than 7 days • fever gets worse or lasts more than 3 days • new symptoms occur • redness or swelling is present. These could be signs of a serious condition.If pregnant or breast-feeding,ask a health care professional before use.

Otc - Do Not Use

Do not use• in a child under 12 years of age • if you are allergic to acetaminophen• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a 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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.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.

Dosage & Administration

Directions• do not use more than directed• take every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctorAGEDOSEAdults and children 12 years of age and overOne packetChildren under 12 years of ageDo not use• dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10 - 15 minutes.• if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat.

Other Safety Information

Other information■each packet contains: Sodium 9.37 mg■ Protect from heat and moisture.■ Do not use if printed packet is torn or punctured.■ Store between 68-77°F (20-25°C)

Inactive Ingredient

Inactive ingredientsCalcium phosphate, Citric acid, Lemon flavour, Malic acid, Sodium citrate, Sucrose, Titanium dioxide

Otc - Questions

Questions?Call 1-888-(OK-HERBION) 654-3724, Monday through Friday, 9am - 5pm EST

* Please review the disclaimer below.