Cold And Flu Nighttime
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
Family Dollar (family Wellness)
Human Otc Drug
NDC 55319-346Cold And Flu Nighttime also known as Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate is a human otc drug labeled by 'Family Dollar (family Wellness)'. National Drug Code (NDC) number for Cold And Flu Nighttime is 55319-346. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Cold And Flu Nighttime drug includes Acetaminophen - 500 mg/15mL Dextromethorphan Hydrobromide - 15 mg/15mL Doxylamine Succinate - 6.25 mg/15mL . The currest status of Cold And Flu Nighttime drug is Active.
Drug Information:
| Drug NDC: | 55319-346 |
| 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 Flu Nighttime |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Cold And Flu |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Nighttime |
| 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, Dextromethorphan Hydrobromide, Doxylamine Succinate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Family Dollar (family Wellness) |
| 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 - 500 mg/15mL
DEXTROMETHORPHAN HYDROBROMIDE - 15 mg/15mL
DOXYLAMINE SUCCINATE - 6.25 mg/15mL
|
| 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: | 31 Mar, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 26 Apr, 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: | 16 Jan, 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: | Family Dollar (FAMILY WELLNESS)
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1042684
|
| 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: | 0032251005053
|
| UPC stands for Universal Product Code. |
| UNII: | 362O9ITL9D
9D2RTI9KYH
V9BI9B5YI2
|
| 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: | Antihistamine [EPC]
Histamine Receptor Antagonists [MoA]
Sigma-1 Agonist [EPC]
Sigma-1 Receptor Agonists [MoA]
Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]
Uncompetitive NMDA Receptor Antagonists [MoA]
|
| 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 |
|---|
| 55319-346-10 | 296 mL in 1 BOTTLE, PLASTIC (55319-346-10) | 31 Mar, 2016 | 26 Apr, 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 cough suppressant antihistamine
Product Elements:
Cold and flu nighttime acetaminophen, dextromethorphan hydrobromide, doxylamine succinate acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan doxylamine succinate doxylamine propylene glycol water alcohol anhydrous citric acid high fructose corn syrup polyethylene glycol, unspecified saccharin sodium trisodium citrate dihydrate d&c yellow no. 10 fd&c green no. 3 fd&c yellow no. 6
Indications and Usage:
Uses temporarily relieves these common cold/flu symptoms: minor aches and pains headache sore throat fever runny nose and sneezing itchy nose or throat coughs cough due to minor throat and bronchial irritation
Warnings:
Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take more than 4 doses (120 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 parkinsons 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 drug containing acetaminophen (prescription or non-prescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist if you are
Read more... allergic to acetaminophen or any of the inactive ingredients in this product ask a doctor before use if you have liver disease glaucoma breathing problems chronic bronchitis a sodium-restricted diet trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma or emphysema or if cough is accompanied by excessive phlegm (mucus) ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers the blood thinning drug warfarin when using this product do not use more than directed (see overdose warning) excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives and tranquilizers may increase drowsiness stop use and ask a doctor if redness or swelling is present new symptoms occur fever gets worse or lasts more than 3 day pain or cough gets worse or lasts more than 7 days cough comes back or occurs with 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 liver warning: this product contains acetaminophen. severe liver damage may occur if you take more than 4 doses (120 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 parkinsons 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 drug containing acetaminophen (prescription or non-prescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist if you are allergic to acetaminophen or any of the inactive ingredients in this product ask a doctor before use if you have liver disease glaucoma breathing problems chronic bronchitis a sodium-restricted diet trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma or emphysema or if cough is accompanied by excessive phlegm (mucus) ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers the blood thinning drug warfarin when using this product do not use more than directed (see overdose warning) excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives and tranquilizers may increase drowsiness stop use and ask a doctor if redness or swelling is present new symptoms occur fever gets worse or lasts more than 3 day pain or cough gets worse or lasts more than 7 days cough comes back or occurs with 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) excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives and tranquilizers may increase drowsiness
Dosage and Administration:
Directions take only as recommended (see overdose warning) do not exceed 4 doses in any 24-hour use dosage cup provided ml= milliliter age dose adults & children 12 years and over 30 ml every 6 hrs children 4 to 11 yrs do not use unless directed by a doctor children under 4 yrs do not use when using other day time or night time products, carefully read each label to ensure correct dosing
Stop Use:
Stop use and ask a doctor if redness or swelling is present new symptoms occur fever gets worse or lasts more than 3 day pain or cough gets worse or lasts more than 7 days cough comes back or occurs with 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 of vicks® nyquil®* nighttime cold & flu multi-symptom relief acetaminophen-pain reliever/fever reducer dextromethorphan hbr-cough suppressant doxylamine succinate-antihistamine fl oz (ml) original alcohol 10 % *this product is not manufactured or distributed by procter & gamble, owner of the registered trademark vicks® nyquil®. failure to follow these warnings could result in serious consequences. tamper evident: do not use if printed safety seal around dosage cup or under cap is broken or missing . distributed by: family dollar services, inc., 10401 monroe rd, matthews, nc 28105 usa visit familydollar.com
Product label family wellness nighttime cold & flu original liquid acetaminophen 500 mg, dextromethorphan hbr 15 mg, doxylamine succinate 6.25 mg
Further Questions:
Questions or comments? call 1-877-753-3935 monday-friday 9am-5pm est