Severe Cold And Cough Night Time
Acetaminophen, Diphenhydramine Hcl, Phenylephrine Hcl
Dolgencorp, Inc. (dollar General & Rexall)
Human Otc Drug
NDC 55910-617Severe Cold And Cough Night Time also known as Acetaminophen, Diphenhydramine Hcl, Phenylephrine Hcl is a human otc drug labeled by 'Dolgencorp, Inc. (dollar General & Rexall)'. National Drug Code (NDC) number for Severe Cold And Cough Night Time is 55910-617. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Severe Cold And Cough Night Time drug includes Acetaminophen - 650 mg/30mL Diphenhydramine Hydrochloride - 25 mg/30mL Phenylephrine Hydrochloride - 10 mg/30mL . The currest status of Severe Cold And Cough Night Time drug is Active.
Drug Information:
| Drug NDC: | 55910-617 |
| 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 Night Time |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Severe Cold And Cough |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Night Time |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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 Hcl, Phenylephrine Hcl |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Dolgencorp, Inc. (dollar General & Rexall) |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| 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/30mL
DIPHENHYDRAMINE HYDROCHLORIDE - 25 mg/30mL
PHENYLEPHRINE HYDROCHLORIDE - 10 mg/30mL
|
| 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: | 30 Jun, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 12 Jan, 2024 |
| 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: | 22 Dec, 2025 |
| 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: | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1298348
|
| 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. |
| UPC: | 0715256808057
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 55910-617-08 | 245 mL in 1 BOTTLE, PLASTIC (55910-617-08) | 30 Jun, 2015 | 12 Jan, 2024 | 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 antihistamine/cough suppressant nasal decongestant
Product Elements:
Severe cold and cough night time acetaminophen, diphenhydramine hcl, phenylephrine hcl acetaminophen acetaminophen diphenhydramine hydrochloride diphenhydramine phenylephrine hydrochloride phenylephrine acesulfame potassium alcohol anhydrous citric acid edetate disodium fd&c blue no. 1 fd&c red no. 40 glycerin maltitol propylene glycol water sodium benzoate trisodium citrate dihydrate
Indications and Usage:
Uses temporarily relieves minor aches and pains sneezing headache minor sore throat pain itchy, watery eyes nasal and sinus congestion runny nose cough due to minor throat and bronchial irritation itchy nose or throat temporarily reduces fever
Warnings:
Warnings allergy alert: acetaminophen may cause severe skin reactions. symptoms may include: skin reddening blisters rash liver warning: this product contains acetaminophen. severe liver damage may occur if you take: more than 6 doses (12 tablespoons or 180 ml) 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 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 to make a child sleepy if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric or emotional conditions, or parkinsonâs 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. with any other product containing diphenh
Read more...ydramine, even one used on skin with any other product containing acetaminophen (prescription or non-prescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ask a doctor before use if you have liver disease glaucoma heart disease thyroid disease high blood pressure diabetes cough accompanied by excessive phlegm (mucus) trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma, or emphysema ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin sedatives or tranquilizers when using this product do not use more than directed (see overdose warning) avoid alcoholic drinks marked drowsiness may occur 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 redness or swelling is present nervousness, dizziness, or sleeplessness occurs pain, cough or nasal congestion gets worse or lasts more than 7 days new symptoms occur fever gets worse or lasts more than 3 days cough comes back or occurs with a fever, rash or headache that lasts. these could be signs of a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. overdose warning : taking more than the recommended dose (overdose) may cause liver damage. in case of overdose, get medical help or contact a poison control center (1-800-222-1222) immediately. quick 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 allergy alert: acetaminophen may cause severe skin reactions. symptoms may include: skin reddening blisters rash liver warning: this product contains acetaminophen. severe liver damage may occur if you take: more than 6 doses (12 tablespoons or 180 ml) 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 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 to make a child sleepy if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric or emotional conditions, or parkinsonâs 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. with any other product containing diphenhydramine, even one used on skin with any other product containing acetaminophen (prescription or non-prescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ask a doctor before use if you have liver disease glaucoma heart disease thyroid disease high blood pressure diabetes cough accompanied by excessive phlegm (mucus) trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma, or emphysema ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin sedatives or tranquilizers when using this product do not use more than directed (see overdose warning) avoid alcoholic drinks marked drowsiness may occur 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 redness or swelling is present nervousness, dizziness, or sleeplessness occurs pain, cough or nasal congestion gets worse or lasts more than 7 days new symptoms occur fever gets worse or lasts more than 3 days cough comes back or occurs with a fever, rash or headache that lasts. these could be signs of a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. overdose warning : taking more than the recommended dose (overdose) may cause liver damage. in case of overdose, get medical help or contact a poison control center (1-800-222-1222) immediately. quick 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 use more than directed (see overdose warning) avoid alcoholic drinks marked drowsiness may occur 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 take more than directed (see overdose warning) do not take more than 6 doses in any 24-hour period measure only with dosing cup provided. do not use any other dosing device ml=milliliter keep dosing cup with product adults and children 12 years and over 30 ml every 4 hours children under 12 years of age; do not use
Stop Use:
Stop use and ask a doctor if redness or swelling is present nervousness, dizziness, or sleeplessness occurs pain, cough or nasal congestion gets worse or lasts more than 7 days new symptoms occur fever gets worse or lasts more than 3 days cough comes back or occurs with a fever, rash or headache that lasts. these could be signs of a serious condition.
Package Label Principal Display Panel:
Principal display panel compare to the active ingredients in theraflu® nighttime severe cold & cough* for ages 12 & over nighttime severe cold and cough acetaminophen pain reliever; fever reducer diphenhydramine hcl cough suppressant; antihistamine phenylephrine hcl nasal decongestant alcohol 10% cherry flavor for ages 12 & over fl oz (ml) tamper evident: do not use if printed safety seal around or under cap is broken or missing. *this product is not manufactured or distributed by novartis consumer health, inc., owner of the registered trademark theraflu® nighttime severe cold & cough.
Product label dollar general night time severe cold and cough acetaminophen 650 mg, diphenhydramine hcl 25 mg, phenylephrine hcl 10 mg