Maximum Strength Day-night Cold And Flu Formula
Acetaminophen, Dextromethorphan, Phenylephrine Hcl
Family Dollar
Human Otc Drug
NDC 55319-935Maximum Strength Day-night Cold And Flu Formula also known as Acetaminophen, Dextromethorphan, Phenylephrine Hcl is a human otc drug labeled by 'Family Dollar'. National Drug Code (NDC) number for Maximum Strength Day-night Cold And Flu Formula is 55319-935. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Maximum Strength Day-night Cold And Flu Formula drug includes . The currest status of Maximum Strength Day-night Cold And Flu Formula drug is Active.
Drug Information:
| Drug NDC: | 55319-935 |
| 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: | Maximum Strength Day-night Cold And Flu Formula |
| 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 Hcl |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Family Dollar |
| 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: | 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: | 02 Aug, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 Dec, 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: | FAMILY DOLLAR
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1086997
1297288
1297404
|
| 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: | 0032251628559
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 55319-935-02 | 1 KIT in 1 BLISTER PACK (55319-935-02) * 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (55319-933-22) * 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (55319-934-08) | 02 Aug, 2020 | 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
Pain reliever-fever reducer cough suppressant antihistamine /nasal decongestant
Product Elements:
Maximum strength day-night cold and flu formula acetaminophen, dextromethorphan, phenylephrine hcl maximum strenght day cold and flu formula acetaminophen, dextromethorphan, phenylephrine hcl shellac titanium dioxide acetaminophen acetaminophen phenylephrine hydrochloride phenylephrine fd&c yellow no. 6 fd&c red no. 40 propylene glycol water sorbitol polyethylene glycol, unspecified povidone gelatin dextromethorphan hydrobromide dextromethorphan glycerin 70 maximum strenth night cold and flu formula acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl dextromethorphan hydrobromide dextromethorphan phenylephrine hydrochloride phenylephrine sorbitol titanium dioxide acetaminophen acetaminophen doxylamine succinate doxylamine fd&c blue no. 1 polyethylene glycol, unspecified povidone propylene glycol gelatin glycerin water shellac 72
Indications and Usage:
Pain reliever-fever reducer cough suppressant antihistamine nasal decongestant nasal congestion headache & body ache cough runny nose sore throat
Uses · temporarily relieves these symptoms due to a cold or flu: · minor aches and pains · headache · cough · sore throat · nasal and sinus congestion · 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 or severe allergic reactions. symptoms may include: · skin reddening · blisters · rash · hives · facial swelling · asthma (wheezing) · shock if a skin or general allergic 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 aloholic drinks every day while using this product l allergy alert: acetaminophen may cause severe skin or severe allergic reactions. symptoms may include: · skin reddening · blisters · rash · hives · facial swelling · asthma (wheezing) · shock if a skin or general allergic 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.
Dosage and Administration:
Directions · do not take more than the recommended dose · adults and children 12 years and over: take 2 capsules with water every 4 hours. do not exceed 10 capsules in 24 hours or as directed by a doctor. · children under 12 years: do not use
Directions · do not take more than the recommended dose · adults and children 12 years and over: take 2 capsules with water every 4 hours. do not exceed 10 capsules in 24 hours or as directed by a doctor. · children under 12 years: do not use
Package Label Principal Display Panel:
20ct