Sanatos Severe Cold And Cough Nighttime
Acetaminophen, Diphenhydramine Hydrochloride, And Phenylephrine Hydrochloride
Pharmadel Llc
Human Otc Drug
NDC 55758-009Sanatos Severe Cold And Cough Nighttime also known as Acetaminophen, Diphenhydramine Hydrochloride, And Phenylephrine Hydrochloride is a human otc drug labeled by 'Pharmadel Llc'. National Drug Code (NDC) number for Sanatos Severe Cold And Cough Nighttime is 55758-009. This drug is available in dosage form of Granule, For Solution. The names of the active, medicinal ingredients in Sanatos Severe Cold And Cough Nighttime drug includes Acetaminophen - 650 mg/1 Diphenhydramine Hydrochloride - 25 mg/1 Phenylephrine Hydrochloride - 10 mg/1 . The currest status of Sanatos Severe Cold And Cough Nighttime drug is Active.
Drug Information:
| Drug NDC: | 55758-009 |
| 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: | Sanatos Severe Cold And Cough 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, Diphenhydramine Hydrochloride, And Phenylephrine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Pharmadel Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Granule, 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
DIPHENHYDRAMINE HYDROCHLORIDE - 25 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: | 20 Feb, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 Jun, 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: | Pharmadel LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1659960
|
| 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
TC2D6JAD40
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]
Histamine H1 Receptor Antagonists [MoA]
Histamine-1 Receptor Antagonist [EPC]
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 |
|---|
| 55758-009-01 | 1 GRANULE, FOR SOLUTION in 1 POUCH (55758-009-01) | 20 Feb, 2014 | N/A | No |
| 55758-009-06 | 6 GRANULE, FOR SOLUTION in 1 CARTON (55758-009-06) | 20 Feb, 2014 | N/A | No |
| 55758-009-18 | 18 GRANULE, FOR SOLUTION in 1 CARTON (55758-009-18) | 01 Mar, 2017 | 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:
Active ingredients (in each packet) purposes acetaminophen 650 mg pain reliever/ fever reducer diphenhydramine hci 25 mg antihistamine/ cough suppressant phenylephrine hci 10 mg nasal decongestant
Product Elements:
Sanatos severe cold and cough nighttime acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride diphenhydramine hydrochloride diphenhydramine phenylephrine hydrochloride phenylephrine acesulfame potassium aspartame anhydrous citric acid d&c yellow no. 10 fd&c blue no. 1 fd&c red no. 40 maltodextrin silicon dioxide sodium citrate sucrose tribasic calcium phosphate acetaminophen acetaminophen water isopropyl alcohol
Indications and Usage:
Uses temporarily relieves common cold/flu symptoms: headache sore throat minor aches & pains nasal congestion & itchy, watery eyes due to hay fever other respiratory allergies cough due to minor throat & bronchial irritation itchy nose and throat runny nose sneezing stuffy nose and reduces fever
Warnings:
Warnings liver warning: this product contains acetaminophen . severe liver damage may occur if you take more than 6 doses 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 with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, 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 st
Read more...opping the maoi drug. if you do not know if your prescription drug contains an maoi, ask a doctor or pharmacist before taking this product. for more than 7 days for pain and 3 days for fever, unless directed by a doctor with any other product containing diphenhydramine, even one used on skin ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes glaucoma a breathing problem such as emphysema chronic bronchitis trouble urinating due to enlarged prostate gland ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers when using this product may cause excitability especially in children may cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect avoid alcoholic beverages while taking this product use caution when driving a motor vehicle or operating machinery stop use and ask doctor if new symptoms occur pain or fever persists or gets worse symptoms do not improve within 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. these could be signs of a serious condition. if nervousness, dizziness, or sleeplessness occur if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of accidental 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.
Do Not Use:
Warnings liver warning: this product contains acetaminophen . severe liver damage may occur if you take more than 6 doses 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 with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, 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 an maoi, ask a doctor or pharmacist before taking this product. for more than 7 days for pain and 3 days for fever, unless directed by a doctor with any other product containing diphenhydramine, even one used on skin ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes glaucoma a breathing problem such as emphysema chronic bronchitis trouble urinating due to enlarged prostate gland ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers when using this product may cause excitability especially in children may cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect avoid alcoholic beverages while taking this product use caution when driving a motor vehicle or operating machinery stop use and ask doctor if new symptoms occur pain or fever persists or gets worse symptoms do not improve within 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. these could be signs of a serious condition. if nervousness, dizziness, or sleeplessness occur if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of accidental 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.
When Using:
When using this product may cause excitability especially in children may cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect avoid alcoholic beverages while taking this product use caution when driving a motor vehicle or operating machinery
Dosage and Administration:
Directions do not exceed recommended dosage take every 4 hours; do not take more than 6 packets in 24- hour period dissolve contents of one packet into 8 oz. hot water and 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. age dose adults & children 12 years of age & over one packet every 4 hours children under 12 years of age do not use
Age dose adults & children 12 years of age & over one packet every 4 hours children under 12 years of age do not use
Stop Use:
Stop use and ask doctor if new symptoms occur pain or fever persists or gets worse symptoms do not improve within 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. these could be signs of a serious condition. if nervousness, dizziness, or sleeplessness occur
Package Label Principal Display Panel:
Principal display panel sanatos ®severe cold & cough nighttime ndc 55758-009-01 ndc 55758-009-06 label
Further Questions:
Questions or comments? 1-866-359-3478 (m-f) 9 am to 5 pm est or www.pharmadel.com