Nite-time Cold/flu Medicine Cherry

Acetaminophen


Aptapharma Inc.
Human Otc Drug
NDC 76281-502
Nite-time Cold/flu Medicine Cherry also known as Acetaminophen is a human otc drug labeled by 'Aptapharma Inc.'. National Drug Code (NDC) number for Nite-time Cold/flu Medicine Cherry is 76281-502. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Nite-time Cold/flu Medicine Cherry drug includes Acetaminophen - 650 mg/30mL Dextromethorphan Hydrobromide - 30 mg/30mL Doxylamine Succinate - 12.5 mg/30mL . The currest status of Nite-time Cold/flu Medicine Cherry drug is Active.

Drug Information:

Drug NDC: 76281-502
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: Nite-time Cold/flu Medicine Cherry
Also known as the trade name. It is the name of the product chosen by the labeler.
Proprietary Name Base: Nite-time
The base of the Brand/Proprietary name excluding its suffix.
Proprietary Name Suffix: COLD/FLU Medicine Cherry
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
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Aptapharma Inc.
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
DEXTROMETHORPHAN HYDROBROMIDE - 30 mg/30mL
DOXYLAMINE SUCCINATE - 12.5 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: 01 Jan, 2018
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 22 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:AptaPharma Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:1043400
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.
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 NDCDescriptionMarketing Start DateMarketing End DateSample Available
76281-502-25177 mL in 1 BOTTLE (76281-502-25)01 Jan, 2018N/ANo
76281-502-28354 mL in 1 BOTTLE (76281-502-28)01 Jan, 2018N/ANo
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:

Purpose purpose pain reliever/fever reducer cough suppressant antihistamine

Product Elements:

Nite-time cold/flu medicine cherry acetaminophen acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan doxylamine succinate doxylamine citric acid monohydrate fd&c blue no. 1 fd&c red no. 40 glycerin polyethylene glycol 400 propylene glycol water saccharin sodium sodium benzoate sodium citrate sucrose cherry flavor

Indications and Usage:

Uses uses temporarily relieves cold/flu symptoms sore throat minor aches and pain runny nose and sneezing cough due to minor sore throat and bronchial irritation headache fever

Warnings:

Warnings failure to follow these warnings could result in serious consequences warnings liver warnings: this product contains acetaminophen. sever liver damage may occur if you take *more than 4 doses 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:

Warnings failure to follow these warnings could result in serious consequences warnings liver warnings: this product contains acetaminophen. sever liver damage may occur if you take *more than 4 doses 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.

When Using:

When using this product when using this product do not use more than directed avoid alcohol drinks excitability may occur, especially in children marked drowsiness may occur 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 use dose cup or tablespoon (tbsp) do not exceed 4 doses per 24 hours ---------------------------------------------------------------------------------------------------------------------- adults and children 12 years and over 30 ml (2 tbsp) every 6 hours ____________________________________________________________________ children 4 to under 12 years ask a doctor ____________________________________________________________________ children under 4 years do not use ____________________________________________________________________ if taking nite time at night and day time during the day, limit total to 4 doses per 24 hours

Stop Use:

Stop use and ask a doctor if redness or swelling is present symptoms do not get better within 7 days or are accompanied by a fever fever gets worse or lasts more than 3 days new symptoms occur cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts these could be signs of a serious condition.

Overdosage:

Overdose warning overdose warning: taking more than the recommended dose can cause serious health problems. in case of overdose, get medical help or contact a poison control center right away. quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Package Label Principal Display Panel:

Package label - night time multi-symptom cherry flavor ndc 76281-502-28 ap safe *compare to the active ingredients in vicks ® nyquil ® night time acetaminophen – pain reliever/fever reducer dextromethorphan hbr – cough suppressant doxylamine succinate – antihistamine multi-symptom cold & flu relief cherry flavor 12 fl oz (354 ml) do notuse if imprintedshrink band is missing or broken failure to follow these warnings could result in serious consequences drug facts active ingredients (in each 30 ml dose cup) purpose acetaminophen 650 mg…………………………………pain reliever/fever reducer dextromethorphan hbr 30 mg………………………….………cough suppressant doxylamine succinate 12.5 mg……………………………..…………antihistamine uses temporarily relieves cold/flu symptoms: ■ sore throat ■ headache ■ minor aches and pains ■ fever ■ runny nose and sneezing ■ cough due to minor throat and bronchial irritation 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 reactions. symptoms may include: ■ skin reddening ■ blisters ■ rash if a skin reaction occurs, stop use and seek medical help right away. sore throat warning: if sore throat is severe, persists for more than two days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. do not use ■ with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist ■ for more than 10 days for pain unless directed by a doctor ■ for more than 3 days for fever unless directed by a doctor. ■ if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric or emotional conditions, or parkinson’s 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 a pharmacist before taking this product ■ to make a child sleepy ask a doctor before use if you have ■ a sodium restricted diet ■ liver disease ■ glaucoma ■ cough that occurs with too much phlegm (mucus) ■ a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema ■ trouble urinating due to enlarged prostrate gland ask a doctor or pharmacist before use ■ if you are taking sedatives or tranquilizers ■ if you are taking the blood thinning drug warfarin when using this product ■ do not use more than directed ■ avoid alcoholic drinks ■ excitability may occur, especially in children ■ marked drowsiness may occur ► drug facts (continued) ■ 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 ■ symptoms do not get better within 7 days or are accompanied by a fever ■ fever gets worse or lasts more than 3 days ■ new symptoms occur ■ cough lasts more than 7 days, comes back, or occurs with 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 accidental overdose, get medical help or contact a poison control center right away. prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. b ■ take only as recommended-see overdose warning ■ use dose cup or tablespoon (tbsp) ■ do not exceed 4 doses per 24 hours ■ if taking night time at night and day time during the day, limit total to 4 doses per 24 hours. adults & children 12 years and over 30 ml (2 tbsp) every 6 hours children 4 to under 12 years ask a doctor children under 4 years do not use other information ■ each 30 ml dose cup made in usa contains: sodium 45 mg ■ store at room temperature ap-lr-09 inactive ingredients citric acid, fd&c blue no.1, fd&c red no. 40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose questions? call weekdays 1-877-798-5944 *this product is not manufactured or distributed by procter & gamble, owner of the registered trademark vicks ® nyquil ® . manufactured by: aptapharma inc., 1533 union ave., pennsauken, nj 08110 12 oz 6 oz res cherry 502 6oz label


Comments/ Reviews:

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