NDC 68210-5005 Multi-symptom Nitetime

Acetaminophen,Dextromethorphan Hydrobromide,And Doxylamine Succinate Capsule, Liquid - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
68210-5005
Proprietary Name:
Multi-symptom Nitetime
Non-Proprietary Name: [1]
Acetaminophen, Dextromethorphan Hydrobromide, And Doxylamine Succinate
Substance Name: [2]
Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Spirit Pharmaceuticals Llc
    Labeler Code:
    68210
    FDA Application Number: [6]
    M012
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    12-12-2022
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    GREEN (C48329)
    Shape:
    CAPSULE (C48336)
    Size(s):
    20 MM
    Imprint(s):
    215
    Score:
    1

    Product Packages

    NDC Code 68210-5005-1

    Package Description: 1 BLISTER PACK in 1 CARTON / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

    NDC Code 68210-5005-2

    Package Description: 2 BLISTER PACK in 1 CARTON / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

    NDC Code 68210-5005-4

    Package Description: 4 BLISTER PACK in 1 CARTON / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

    Product Details

    What is NDC 68210-5005?

    The NDC code 68210-5005 is assigned by the FDA to the product Multi-symptom Nitetime which is a human over the counter drug product labeled by Spirit Pharmaceuticals Llc. The generic name of Multi-symptom Nitetime is acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate. The product's dosage form is capsule, liquid filled and is administered via oral form. The product is distributed in 3 packages with assigned NDC codes 68210-5005-1 1 blister pack in 1 carton / 10 capsule, liquid filled in 1 blister pack, 68210-5005-2 2 blister pack in 1 carton / 12 capsule, liquid filled in 1 blister pack, 68210-5005-4 4 blister pack in 1 carton / 12 capsule, liquid filled in 1 blister pack. 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 Nitetime?

    Take only as recommended—see Overdose warning. do not exceed 4 doses per 24 hours adults and children 12 years of age and overswallow 2 softgels with water every 6 hourschildren 4 to under 12 years of ageask a doctorchildren under 4 years of agedo not useIf taking Nighttime and Daytime softgels carefully read each label to insure correct dosing

    What are Multi-symptom Nitetime Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • ACETAMINOPHEN 325 mg/1 - Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.
    • DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 - Methyl analog of DEXTRORPHAN that shows high affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist (RECEPTORS, N-METHYL-D-ASPARTATE) and acts as a non-competitive channel blocker. It is one of the widely used ANTITUSSIVES, and is also used to study the involvement of glutamate receptors in neurotoxicity.
    • DOXYLAMINE SUCCINATE 6.25 mg/1

    Which are Multi-symptom Nitetime UNII Codes?

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

    Which are Multi-symptom Nitetime 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:

    What is the NDC to RxNorm Crosswalk for Multi-symptom Nitetime?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • RxCUI: 1094549 - acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule
    • RxCUI: 1094549 - acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule
    • RxCUI: 1094549 - APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule

    Which are the Pharmacologic Classes for Multi-symptom Nitetime?

    * Please review the disclaimer below.

    Patient Education

    Acetaminophen


    Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
    [Learn More]


    Dextromethorphan


    Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
    [Learn More]


    Doxylamine


    Doxylamine is used in the short-term treatment of insomnia (difficulty falling asleep or staying asleep). Doxylamine is also used in combination with decongestants and other medications to relieve sneezing, runny nose, and nasal congestion caused by the common cold. Doxylamine should not be used to cause sleepiness in children. Doxylamine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
    [Learn More]


    * Please review the disclaimer below.

    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.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [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".