Severe Cold And Cough Daytime
Acetaminophen, Dextromethorphan, Phenylephrine
Chain Drug Manufacturing Assn
Human Otc Drug
NDC 63868-290Severe Cold And Cough Daytime also known as Acetaminophen, Dextromethorphan, Phenylephrine is a human otc drug labeled by 'Chain Drug Manufacturing Assn'. National Drug Code (NDC) number for Severe Cold And Cough Daytime is 63868-290. This drug is available in dosage form of Powder, For Solution. The names of the active, medicinal ingredients in Severe Cold And Cough Daytime drug includes Acetaminophen - 650 mg/1 Dextromethorphan Hydrobromide - 20 mg/1 Phenylephrine Hydrochloride - 10 mg/1 . The currest status of Severe Cold And Cough Daytime drug is Active.
Drug Information:
| Drug NDC: | 63868-290 |
| 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: | Severe Cold And Cough Daytime |
| 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, Dextromethorphan, Phenylephrine |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Chain Drug Manufacturing Assn |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Powder, For Solution |
| 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 - 650 mg/1
DEXTROMETHORPHAN HYDROBROMIDE - 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: | 25 Jul, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 Jan, 2025 |
| 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: | 31 Dec, 2023 |
| 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: | Chain Drug Manufacturing Assn
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1659967
|
| 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
9D2RTI9KYH
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]
Sigma-1 Agonist [EPC]
Sigma-1 Receptor Agonists [MoA]
Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]
Uncompetitive NMDA Receptor Antagonists [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 |
|---|
| 63868-290-06 | 6 PACKET in 1 CARTON (63868-290-06) / 1 POWDER, FOR SOLUTION in 1 PACKET | 25 Jul, 2018 | N/A | 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:
Purposes pain reliever / fever reducer cough suppressant nasal decongestant
Product Elements:
Severe cold and cough daytime acetaminophen, dextromethorphan, phenylephrine acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan phenylephrine hydrochloride phenylephrine anhydrous citric acid fd&c blue no. 1 fd&c red no. 40 maltodextrin potassium chloride silicon dioxide sucralose sucrose infused with menthol and green tea flavors
Indications and Usage:
Uses ? temporarily relieves these symptoms due to a cold: ? minor aches and pains ? minor sore throat pain ? headache ? nasal and sinus congestion ? cough due to minor throat and bronchial irritation ? temporarily reduces fever
Warnings:
Warnings liver 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 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 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,
Read more... 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. ask doctor before use if you have ? liver disease ? heart disease ? high blood pressure ? thyroid disease ? diabetes ? trouble urinating due to an enlarged prostate gland ? cough that occurs with too much phlegm (mucus) ? cough that lasts or is chronic such as occurs with smoking, asthma or emphysema ask a doctor or pharmacist before use if you are ? 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 occurs ? fever gets worse or lasts more than 3 days ? redness or swelling is present ? new symptoms occur ? symptoms do not get better or worsen ? pain, cough or nasal congestion gets worse or lasts more than 7 days ? cough comes back or occurs fever, rash or headache that lasts. these could be signs of a serious condition. if pregnant or breast-feeding, ask a health care professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away at 1-800-222-1222. prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Do Not Use:
Warnings liver 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 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 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. ask doctor before use if you have ? liver disease ? heart disease ? high blood pressure ? thyroid disease ? diabetes ? trouble urinating due to an enlarged prostate gland ? cough that occurs with too much phlegm (mucus) ? cough that lasts or is chronic such as occurs with smoking, asthma or emphysema ask a doctor or pharmacist before use if you are ? 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 occurs ? fever gets worse or lasts more than 3 days ? redness or swelling is present ? new symptoms occur ? symptoms do not get better or worsen ? pain, cough or nasal congestion gets worse or lasts more than 7 days ? cough comes back or occurs fever, rash or headache that lasts. these could be signs of a serious condition. if pregnant or breast-feeding, ask a health care professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away at 1-800-222-1222. prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
When Using:
When using this product do not exceed recommended dosage
Dosage and Administration:
Directions ? do not use more than directed ? take every 4 hours; while symptoms persist. do not to exceed 5 packets in 24 hours unless directed by a doctor age dose adults and children 12 years of age and over one packet children under 12 years of age 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 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 ? fever gets worse or lasts more than 3 days ? redness or swelling is present ? new symptoms occur ? symptoms do not get better or worsen ? pain, cough or nasal congestion gets worse or lasts more than 7 days ? cough comes back or occurs fever, rash or headache that lasts. these could be signs of a serious condition.
Package Label Principal Display Panel:
Principal display qc quality choice *compare to the active ingredients in theraflu ® daytime severe cold &cough severe cold & cough daytime acetaminophen pain reliever/ fever reducer dextromethorphan hbr cough suppressant phenylephrine hcl nasal decongestant aspartame free ?sodium free relieves: nasal congestion cough/body ache sore throat pain headache/fever berry infused with menthol & green tea flavors 6 packets read all warnings and directions on carton before use, keep carton for reference, do not discard, *this product is not manufactured or distributed by gsk consumer healthcare, distributor of theraflu ® daytime severe cough & cold tamper evident inner unit: do not use if sealed packet is torn or broken. distributed by: c.d.m.a., inc 43157 w. 9 mile rd novi, mi 48375 www.qualitychoice.com questions: 248-449-9300 qc quality choice severe cold and cough daytime berry infused with menthol and green tea flavors 6 packets
Further Questions:
Questions or comments? 1-866-467-2748