Cooling Severe Daytime Cooling Severe Nighttime
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride,guaifenesin
Cvs Pharmacy
Human Otc Drug
NDC 69842-737Cooling Severe Daytime Cooling Severe Nighttime also known as Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride,guaifenesin is a human otc drug labeled by 'Cvs Pharmacy'. National Drug Code (NDC) number for Cooling Severe Daytime Cooling Severe Nighttime is 69842-737. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Cooling Severe Daytime Cooling Severe Nighttime drug includes . The currest status of Cooling Severe Daytime Cooling Severe Nighttime drug is Active.
Drug Information:
| Drug NDC: | 69842-737 |
| 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: | Cooling Severe Daytime Cooling Severe Nighttime |
| 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 Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride,guaifenesin |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Cvs Pharmacy |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| 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: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | |
| 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: | 23 Jul, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 06 May, 2026 |
| 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: | CVS Pharmacy
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1369842
1431245
|
| 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: | |
| 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. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 69842-737-02 | 1 KIT in 1 PACKAGE (69842-737-02) * 355 mL in 1 BOTTLE (69842-182-40) * 355 mL in 1 BOTTLE (69842-590-40) | 23 Jul, 2019 | 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:
Purpose pain reliever/fever reducer cough suppressant antihistamine nasal decongestant
Purpose pain reliever/fever reducer cough suppressant expectorant nasal decongestant
Product Elements:
Cooling severe daytime cooling severe nighttime acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride,guaifenesin cooling severe nighttime acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan doxylamine succinate doxylamine phenylephrine hydrochloride phenylephrine alcohol anhydrous citric acid d&c yellow no. 10 edetate disodium fd&c blue no. 1 glycerin polyethylene glycol, unspecified propylene glycol water saccharin sodium sodium benzoate sodium chloride sodium citrate, unspecified form sorbitol sucralose cooling severe daytime acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan guaifenesin guaifenesin phenylephrine hydrochloride phenylephrine alcohol anhydrous citric acid d&c yellow no. 10 edetate disodium fd&c blue no. 1 glycerin polyethylene glycol, unspecified propylene glycol water saccharin sodium sodium benzoate sodium chloride sodium citrate, unspecified form sorbitol sucralose
Indications and Usage:
Uses temporarily relieves common cold/flu symptoms: ⢠nasal congestion ⢠sinus congestion and pressure ⢠minor aches and pains ⢠headache ⢠sore throat ⢠runny nose and sneezing ⢠cough to help you sleep ⢠cough due to minor throat and bronchial irritation ⢠reduces swelling of nasal passages ⢠fever ⢠promotes nasal and/or sinus drainage ⢠temporarily restores freer breathing through the nose
Uses temporarily relieves common cold/flu symptoms: ⢠nasal congestion ⢠sinus congestion and pressure ⢠cough due to minor throat and bronchial irritation ⢠minor aches and pains ⢠headache ⢠fever ⢠reduces swelling of nasal passages ⢠temporarily restores freer breathing through the nose ⢠sore throat ⢠helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive ⢠promotes nasal and/or sinus drainage
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.
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:
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.
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.
When Using:
When using this product ⢠do not use more than directed ⢠excitability may occur, especially in children ⢠be careful when driving a motor vehicle or operating machinery ⢠marked drowsiness may occur ⢠alcohol, sedatives, and tranquilizers may increase drowsiness ⢠avoid alcoholic drinks
When using this product do not use more than directed
Dosage and Administration:
Directions ⢠take only as directed â see overdose warning ⢠only use the dose cup provided ⢠do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 ml every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use
Directions ⢠take only as directed â see overdose warning ⢠only use the dose cup provided ⢠do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 ml every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use
Stop Use:
Stop use and ask a doctor if ⢠pain, nasal congestion, or cough gets worse or lasts more than 7 days ⢠you get nervous, dizzy or sleepless ⢠fever gets worse or lasts more than 3 days ⢠redness or swelling is present ⢠new symptoms occur ⢠cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition.
Stop use and ask a doctor if ⢠you get nervous, dizzy or sleepless ⢠pain, nasal congestion, or cough gets worse or lasts more than 7 days ⢠fever gets worse or lasts more than 3 days ⢠redness or swelling is present ⢠new symptoms occur ⢠cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition.
Package Label Principal Display Panel:
Package/label principal display panel compare to the active ingredients in vicks ® dayquil ® severe+vapocool ⢠cooling severe daytime cold & flu relief acetaminophen â pain reliever/fever reducer phenylephrine hcl â nasal decongestant dextromethorphan hbr â cough suppressant guaifenesin â expectorant relieves: minor aches, pains & fever nasal congestion & sinus pressure cough chest congestion alcohol 10% 12 fl oz (355 ml) compare to the active ingredients in vicks ® nyquil ® severe+vapocool ⢠cooling severe nighttime cold & flu relief acetaminophen â pain reliever/fever reducer phenylephrine hcl â nasal decongestant doxylamine succinate - antihistamine dextromethorphan hbr â cough suppressant relieves: minor aches, pains & fever nasal congestion & sinus pressure sneezing, runny nose cough alcohol 10% 12 fl oz (355 ml) daytime nighttime cold and flu image 1 daytime nighttime cold and flu image 2
Further Questions:
Questions or comments? 1-800-719-9260
Questions or comments? 1-800-719-9260