NDC 51316-559 Multi Symptom Flu Relief Max Strength Daytime Nighttime Combo Pack

Acetaminophen,Dextromethorphan Hbr,And Acetaminophen,Chlorpheniramine - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
51316-559
Proprietary Name:
Multi Symptom Flu Relief Max Strength Daytime Nighttime Combo Pack
Non-Proprietary Name: [1]
Acetaminophen, Dextromethorphan Hbr, And Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hbr
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Labeler Name: [5]
Labeler Code:
51316
FDA Application Number: [6]
M012
Marketing Category: [8]
OTC MONOGRAPH DRUG -
Start Marketing Date: [9]
04-21-2023
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
N
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - TO OFF WHITE, YELLOW, BEIGE, AND BROWN COLOR)
WHITE (C48325 - WHITE TO OFF-WHITE, YELLOW, BEIGE, AND BROWN COLOR)
Flavor(s):
HONEY (C73394 - LEMON)

Code Structure Chart

Product Details

What is NDC 51316-559?

The NDC code 51316-559 is assigned by the FDA to the product Multi Symptom Flu Relief Max Strength Daytime Nighttime Combo Pack which is a human over the counter drug product labeled by Cvs Pharmacy. The generic name of Multi Symptom Flu Relief Max Strength Daytime Nighttime Combo Pack is acetaminophen, dextromethorphan hbr, and acetaminophen, chlorpheniramine maleate, dextromethorphan hbr. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 51316-559-06 1 kit in 1 carton * 6 powder in 1 carton (51316-558-06) * 6 powder in 1 carton (51316-560-06). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Multi Symptom Flu Relief Max Strength Daytime Nighttime Combo Pack?

▪do not use more than directed▪take every 6 hours, while symptoms persist. Do not take more than 3 packets in 24 hours unless directed by a doctor. Age Dose adults and children 12 years of age and over one packet children under 12 years of age do not use▪dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume the 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. ▪do not use more than directed▪take every 6 hours, while symptoms persist. Do not take more than 3 packets in 24 hours unless directed by a doctor. Age Dose adults and children 12 years of age and over one packet children under 12 years of age do not use▪dissolve contents of one packet into 8 oz. hot water; 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

Which are Multi Symptom Flu Relief Max Strength Daytime Nighttime Combo Pack UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Multi Symptom Flu Relief Max Strength Daytime Nighttime Combo Pack Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

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Product Footnotes

[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] What is the FDA Application Number? - 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.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".