NDC 73147-3173 Cold And Sore Throat

Acetaminophen, Pheniramine Maleate, Phenylephrine Hydrochloride

NDC Product Code 73147-3173

NDC CODE: 73147-3173

Proprietary Name: Cold And Sore Throat 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: Acetaminophen, Pheniramine Maleate, Phenylephrine Hydrochloride 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

  • 73147 - Cellchem Pharmaceuticals Inc

NDC 73147-3173-6

Package Description: 6 POWDER in 1 BOX, UNIT-DOSE

NDC Product Information

Cold And Sore Throat with NDC 73147-3173 is a a human over the counter drug product labeled by Cellchem Pharmaceuticals Inc. The generic name of Cold And Sore Throat is acetaminophen, pheniramine maleate, phenylephrine hydrochloride. The product's dosage form is powder and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1796460.

Dosage Form: Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.

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.

Cold And 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.


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.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POVIDONE (UNII: FZ989GH94E)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • RAW SUGAR (UNII: 8M707QY5GH)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)

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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Cellchem Pharmaceuticals Inc
Labeler Code: 73147
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: 07-01-2019 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: 12-31-2022 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 - NO 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".

* Please review the disclaimer below.

Cold And Sore Throat Product Label Images

Cold And 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

Drug Facts

Active Ingredients (in each packet)                                                PurposeAcetaminophen 325 mg...................................................Pain reliever/Fever reducerPheniramine maleate 20 mg................................................AntihistaminePhenylephrine Hydrochloride 10 mg......................................Nasal decongestant

Uses

  • Temporarily relieves these symptoms due to cold:minor aches and pains minor sore throat painheadachenasal  congestionTemporarily reduces feverTemporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy nose and throat itchy, watery eyes

Warnings

  • Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:more than 6 packets in 24 hours, which is the maximum daily amountwith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this product.Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may includeskin reddeningblistersrash. If 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

  • In children under 12 years of ageif you are allergic to acetaminophenwith any other drug containing acetaminophen (prescription and non-prescription). If you are not sure whether a drug contains  cetaminophen, 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 a MAOI, ask a doctor or pharmacist before taking this product.

When Using This Product

  • Do not exceed recommended dosageavoid alcoholic drinksmay cause drowsiness alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machineryexcitability may occur, especially in children.

Stop 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 occurredness or swelling is present These could be signs of a serious condition.

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.

Directions

  • Do not use more than directedtake every 4 hours, while symptoms persist.Do not take more than 6 packets in 24 hours unless directed by a doctor.AgeDoseadults and children 12 years and overone packetchildren under 12 yearsdo not usedissolve 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.

Information For Patients

  • Other Informationeach packet contains: sodium 70 mgstore at controlled room temperature 20-25°C (68 -77°F). Protect from heat and moisture.

Inactive Ingredients

Citric acid, D&C Yellow 10, Ethylcellulose, FD&C Red 40, Flavor, Microcrystalline cellulose, Povidone, Silicon dioxide, Sodium citrate, Starch, Sugar and Vitamin C

* Please review the disclaimer below.