NDC 44237-043 Childrens Novex Cold Plus Cough Plus Sore Throat

Acetaminophen And Dextromethorphan Hydrobromide

NDC Product Code 44237-043

NDC 44237-043-03

Package Description: 1 BOTTLE in 1 CARTON > 120 mL in 1 BOTTLE

NDC Product Information

Childrens Novex Cold Plus Cough Plus Sore Throat with NDC 44237-043 is a a human over the counter drug product labeled by Herbion Pakistan (pvt.) Ltd. The generic name of Childrens Novex Cold Plus Cough Plus Sore Throat is acetaminophen and dextromethorphan hydrobromide. The product's dosage form is suspension and is administered via oral form.

Labeler Name: Herbion Pakistan (pvt.) Ltd

Dosage Form: Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.

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.

Childrens Novex Cold Plus Cough Plus Sore Throat 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 160 mg/5mL
  • DEXTROMETHORPHAN HYDROBROMIDE 5 mg/5mL

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)
  • SORBITOL SOLUTION (UNII: 8KW3E207O2)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • WATER (UNII: 059QF0KO0R)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)

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: 03-21-2020 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.

Childrens Novex Cold Plus Cough Plus Sore Throat Product Label Images

Childrens Novex Cold Plus Cough Plus Sore Throat 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 ingredients(in each 5mL)Acetaminophen 160 mg Dextromethorphan HBr 5 mg

Otc - Purpose

PurposesFever Reducer / Pain RelieverCough suppressant

Indications & Usage

Uses■ temporarily relieves the following cold/flu symptoms: • minor aches and pains • headache •sore throat • cough■ temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes■ more than 5 doses in 24 hours, which is the maximum daily amount■ with other drugs containing acetaminophenAllergy 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 your child has■ liver disease ■ persistent or chronic cough such as occurs with asthma ■ cough that occurs with too much phlegm (mucus)Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarinWhen using this product do not exceed recommended dose (see overdose warning)Stop use and ask a doctor if■ pain or cough gets worse or lasts more than 5 days■ fever gets worse or lasts more than 3 days■ new symptoms occur■ redness or swelling is present■ cough comes back with rash or headache that lastsThese could be signs of a serious condition

Otc - Do Not Use

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.■ in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.■ if your child has ever had an allergic reaction to this product or any of its ingredients

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Dosage & Administration

Directions■ this product does not contain directions or complete warnings for adult use■ do not give more than directed (see overdose warning)■ shake well before using■ mL = milliliter■ find right dose on chart below. If possible, use weight to dose; otherwise, use age.■ remove the child protective cap and squeeze your child's dose into the dosing cup■ repeat dose every 4 hours, while symptoms last■ do not give more than 5 times in 24 hoursWeight (lb)Age (yr)Dose (mL)*Under 36Under 4 yearsDo not use36-474-5 years5 mL48-956-11 years10 mL*or as directed by a dosctorAttention: use only enclosed dosing cup provided, specifically designed for use with this product.

Other Safety Information

Other Information:■ store between 68-770F (20-250C)■ do not use if bottle cap seal is broken

Inactive Ingredient

Inactive Ingredients:Carboxymethylcellulose sodium, FD&C Red No. 40, Flavor, Glycerin, Potassium Sorbate, Purified water, Sodium benzoate, Sorbitol solution, Sucrose, Sucralose, Xanthan gum

Otc - Questions

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

* Please review the disclaimer below.