Cold And Sore Throat
Acetaminophen, Pheniramine Maleate, Phenylephrine Hydrochloride
Cellchem Pharmaceuticals Inc
Human Otc Drug
NDC 73147-3173Cold And Sore Throat also known as Acetaminophen, Pheniramine Maleate, Phenylephrine Hydrochloride is a human otc drug labeled by 'Cellchem Pharmaceuticals Inc'. National Drug Code (NDC) number for Cold And Sore Throat is 73147-3173. This drug is available in dosage form of Powder. The names of the active, medicinal ingredients in Cold And Sore Throat drug includes Acetaminophen - 325 mg/1 Pheniramine Maleate - 20 mg/1 Phenylephrine Hydrochloride - 10 mg/1 . The currest status of Cold And Sore Throat drug is Active.
Drug Information:
| Drug NDC: | 73147-3173 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Cold And Sore Throat |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Acetaminophen, Pheniramine Maleate, Phenylephrine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Cellchem Pharmaceuticals Inc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Powder |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | ACETAMINOPHEN - 325 mg/1
PHENIRAMINE MALEATE - 20 mg/1
PHENYLEPHRINE HYDROCHLORIDE - 10 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 01 Jul, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 31 Dec, 2023 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part341 |
| 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. |
| Listing Expiration Date: | 06 May, 2026 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Cellchem Pharmaceuticals Inc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1796460
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 362O9ITL9D
NYW905655B
04JA59TNSJ
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Adrenergic alpha1-Agonists [MoA]
alpha-1 Adrenergic Agonist [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 73147-3173-6 | 6 POWDER in 1 BOX, UNIT-DOSE (73147-3173-6) | 01 Jul, 2019 | 31 Dec, 2023 | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Uses ⢠temporarily relieves these symptoms due to cold: o minor aches and pains o minor sore throat pain o headache o nasal congestion ⢠temporarily reduces fever ⢠temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: o runny nose o sneezing o itchy nose and throat o itchy, watery eyes
Product Elements:
Cold and sore throat acetaminophen, pheniramine maleate, phenylephrine hydrochloride acetaminophen acetaminophen pheniramine maleate pheniramine phenylephrine hydrochloride phenylephrine anhydrous citric acid d&c yellow no. 10 fd&c red no. 40 ethylcellulose, unspecified microcrystalline cellulose povidone, unspecified silicon dioxide sodium citrate, unspecified form starch, corn raw sugar ascorbic acid
Indications and Usage:
Relives: ⢠nasal congestion ⢠body aches ⢠headache ⢠runny nose ⢠sore throat pain ⢠fever
Warnings:
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 amount ⢠with other drugs containing acetaminophen ⢠3 or more alcoholic drinks every day while using this product. allergy alert: acetaminophen may cause severe skin reactions. symptoms may include ⢠skin reddening ⢠blisters ⢠rash. 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 age ⢠if you are allergic to acetaminophen ⢠with 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 monoa
Read more...mine 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. 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, asthma, or chronic bronchitis ⢠a sodium restricted diet. ask a doctor or pharmacist before use if you are ⢠taking sedatives or tranquilizers ⢠taking the blood thinning drug warfarin if pregnant or breast-feeding, ask a health care professional before use. when 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 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 occur ⢠redness 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. read all warnings and directions on carton before use. keep carton for reference. do not discard do not use if sealed packet is torn or broken
Read all warnings and directions on carton before use. keep carton for reference. do not discard do not use if sealed packet is torn or broken
Do Not Use:
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 amount ⢠with other drugs containing acetaminophen ⢠3 or more alcoholic drinks every day while using this product. allergy alert: acetaminophen may cause severe skin reactions. symptoms may include ⢠skin reddening ⢠blisters ⢠rash. 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 age ⢠if you are allergic to acetaminophen ⢠with 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. 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, asthma, or chronic bronchitis ⢠a sodium restricted diet. ask a doctor or pharmacist before use if you are ⢠taking sedatives or tranquilizers ⢠taking the blood thinning drug warfarin if pregnant or breast-feeding, ask a health care professional before use. when 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 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 occur ⢠redness 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. read all warnings and directions on carton before use. keep carton for reference. do not discard do not use if sealed packet is torn or broken
Read all warnings and directions on carton before use. keep carton for reference. do not discard do not use if sealed packet is torn or broken
When Using:
When 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 children.
Dosage and Administration:
Directions ⢠do not use more than directed ⢠take every 4 hours, while symptoms persist. do not take more than 6 packets in 24 hours unless directed by a doctor. age dose adults and children 12 years and over one packet children under 12 years do 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.
Stop Use:
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 occur ⢠redness or swelling is present these could be signs of a serious condition.
Package Label Principal Display Panel:
Package label.principal display panel cartonlabel pouch
Further Questions:
Questions, comments or adverse reactions? you may report serious side effects to: +1 844-481-8884 serious side effects can also be reported to: drugsafety@cellchempharma.ca distributed by: cellchem pharmaceuticals inc. unit 1, 30 concourse gate nepean, ontario k2e 7v7