Maximum Strength Nighttime Cold And Flu
Acetaminophen , Diphenhydramine Hcl,phenylephrine Hcl
The Kroger Co
Human Otc Drug
NDC 30142-736Maximum Strength Nighttime Cold And Flu also known as Acetaminophen , Diphenhydramine Hcl,phenylephrine Hcl is a human otc drug labeled by 'The Kroger Co'. National Drug Code (NDC) number for Maximum Strength Nighttime Cold And Flu is 30142-736. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Maximum Strength Nighttime Cold And Flu drug includes Acetaminophen - 650 mg/20mL Diphenhydramine Hydrochloride - 25 mg/20mL Phenylephrine Hydrochloride - 10 mg/20mL . The currest status of Maximum Strength Nighttime Cold And Flu drug is Active.
Drug Information:
| Drug NDC: | 30142-736 |
| 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 Nighttime Cold And Flu |
| 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 , Diphenhydramine Hcl,phenylephrine Hcl |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | The Kroger Co |
| 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/20mL
DIPHENHYDRAMINE HYDROCHLORIDE - 25 mg/20mL
PHENYLEPHRINE HYDROCHLORIDE - 10 mg/20mL
|
| 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: | 04 Sep, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 14 May, 2026 |
| 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: | THE KROGER CO
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1375932
|
| 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
TC2D6JAD40
04JA59TNSJ
|
| 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: | Adrenergic alpha1-Agonists [MoA]
Histamine H1 Receptor Antagonists [MoA]
Histamine-1 Receptor Antagonist [EPC]
alpha-1 Adrenergic Agonist [EPC]
|
| 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 |
|---|
| 30142-736-06 | 180 mL in 1 BOTTLE (30142-736-06) | 04 Sep, 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:
Active ingredients (in each 20 ml) purposes acetaminophen 650 mg pain reliever/fever reducer diphenhydramine hcl 25 mg antihistamine/cough suppressant phenylephrine hcl 10 mg nasal decongestant
Product Elements:
Maximum strength nighttime cold and flu acetaminophen , diphenhydramine hcl,phenylephrine hcl acetaminophen acetaminophen diphenhydramine hydrochloride diphenhydramine phenylephrine hydrochloride phenylephrine anhydrous citric acid edetate disodium fd&c blue no. 1 fd&c red no. 40 potassium citrate propylene glycol propyl gallate water sodium benzoate sorbitol sucralose xanthan gum
Indications and Usage:
Uses ⢠temporarily relieves these common cold and flu symptoms: ⢠cough ⢠nasal congestion ⢠minor aches and pains ⢠sore throat ⢠headache ⢠runny nose ⢠sneezing ⢠temporarily reduces fever ⢠controls cough to help you get to sleep
Warnings:
Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take: ⢠more than 6 doses in 24 hours, which is the maximum daily amount ⢠with other drugs containing acetaminophen ⢠3 or more alcoholic drinks daily while using this product allergy alert: acetaminophen may cause severe skin reactions .symptoms may include: ⢠skin reddening ⢠blisters ⢠rash nan 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 2 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. ⢠with any other drug containing diphenhydramine, even one used on the skin ⢠if you are now taking a prescription monoamine oxi
Read more...dase 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 pharmacist before taking this product. ask a doctor before use if you have ⢠liver disease ⢠heart disease ⢠high blood pressure ⢠thyroid disease ⢠diabetes ⢠trouble urinating due to an enlarged prostate gland ⢠glaucoma ⢠a breathing problem such as emphysema or chronic bronchitis ⢠persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) ask a doctor or pharmacist before use if ⢠you are taking the blood thinning drug warfarin ⢠taking sedatives or tranquilizers when using this product ⢠do not use more than directed ⢠excitability may occur, especially in children ⢠marked drowsiness may occur ⢠alcohol, sedatives, and tranquilizers may increase drowsiness ⢠avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery stop use and ask a doctor if ⢠nervousness, dizziness, or sleeplessness occur ⢠pain, nasal congestion, or cough gets worse or lasts more than 7 days ⢠fever gets worse or lasts more than 3 days ⢠redness or swelling is present ⢠new symptoms occur ⢠cough 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 overdose, get medical help or contact a poison control center right away 1-800-222-1222. 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 6 doses in 24 hours, which is the maximum daily amount ⢠with other drugs containing acetaminophen ⢠3 or more alcoholic drinks daily while using this product allergy alert: acetaminophen may cause severe skin reactions .symptoms may include: ⢠skin reddening ⢠blisters ⢠rash nan 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 2 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. ⢠with any other drug containing diphenhydramine, even one used on the skin ⢠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 pharmacist before taking this product. ask a doctor before use if you have ⢠liver disease ⢠heart disease ⢠high blood pressure ⢠thyroid disease ⢠diabetes ⢠trouble urinating due to an enlarged prostate gland ⢠glaucoma ⢠a breathing problem such as emphysema or chronic bronchitis ⢠persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) ask a doctor or pharmacist before use if ⢠you are taking the blood thinning drug warfarin ⢠taking sedatives or tranquilizers when using this product ⢠do not use more than directed ⢠excitability may occur, especially in children ⢠marked drowsiness may occur ⢠alcohol, sedatives, and tranquilizers may increase drowsiness ⢠avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery stop use and ask a doctor if ⢠nervousness, dizziness, or sleeplessness occur ⢠pain, nasal congestion, or cough gets worse or lasts more than 7 days ⢠fever gets worse or lasts more than 3 days ⢠redness or swelling is present ⢠new symptoms occur ⢠cough 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 overdose, get medical help or contact a poison control center right away 1-800-222-1222. 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 ⢠excitability may occur, especially in children ⢠marked drowsiness may occur ⢠alcohol, sedatives, and tranquilizers may increase drowsiness ⢠avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery
Dosage and Administration:
Directions ⢠do not take more than directed (see overdose warning) ⢠do not take more than 6 doses in any 24-hour period ⢠measure only with dosing cup provided ⢠do not use dosing cup with other products ⢠dose as follows or as directed by a doctor ⢠ml= milliliter ⢠adults and children 12 years of age and older: 20 ml in dosing cup provided every 4 hours ⢠children under 12 years of age: do not use
Stop Use:
Stop use and ask a doctor if ⢠nervousness, dizziness, or sleeplessness occur ⢠pain, nasal congestion, or cough gets worse or lasts more than 7 days ⢠fever gets worse or lasts more than 3 days ⢠redness or swelling is present ⢠new symptoms occur ⢠cough comes back, or occurs with fever, rash, or headache that lasts. these could be signs of a serious condition.
Overdosage:
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 right away 1-800-222-1222. 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:
Principal display panel - ndc# 30142-736-06 compare to mucinex ® fast-max ® maximum strength might time cold & flu active ingredients maximum strength night time cold & flu acetaminophen pain reliever/fever reducer diphenhydramine hcl antihistamine/cough suppressant phenylephrine hcl nasal decongestant relieves: ⢠sore throat; itchy throat-cough ⢠nasal congestion â sneezing & runny nose ⢠headache â body pain for ages 12+ 6 fl oz (180 ml) *this product is not manufactured or distributed by reckitt benckiser, the distributor of mucinex ® fast- max ® maximum strength nighttime cold & flu tamper evident: do not use if printed seal under cap is broken or missing. â¡maximum strength per 4 hour dose. distributed by: maximum strength nighttime cold & flu
Further Questions:
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