Cold And Flu Multi-symptom Relief/cold And Flu Nighttime Relief
Acetaminophen, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide, And Doxylamine Succinate
Aurohealth Llc
Human Otc Drug
NDC 58602-770Cold And Flu Multi-symptom Relief/cold And Flu Nighttime Relief also known as Acetaminophen, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide, And Doxylamine Succinate is a human otc drug labeled by 'Aurohealth Llc'. National Drug Code (NDC) number for Cold And Flu Multi-symptom Relief/cold And Flu Nighttime Relief is 58602-770. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Cold And Flu Multi-symptom Relief/cold And Flu Nighttime Relief drug includes . The currest status of Cold And Flu Multi-symptom Relief/cold And Flu Nighttime Relief drug is Active.
Drug Information:
| Drug NDC: | 58602-770 |
| 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: | Cold And Flu Multi-symptom Relief/cold And Flu Nighttime Relief |
| 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, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide, And Doxylamine Succinate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Aurohealth Llc |
| 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: | |
| 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: | 31 Dec, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 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: | Aurohealth LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1086997
1094549
1311150
|
| 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: | |
| 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 |
|---|
| 58602-770-54 | 1 KIT in 1 PACKAGE (58602-770-54) * 16 BLISTER PACK in 1 CARTON / 2 CAPSULE in 1 BLISTER PACK * 8 BLISTER PACK in 1 CARTON / 2 CAPSULE in 1 BLISTER PACK | 31 Dec, 2019 | 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:
Purpose - day time pain reliever/fever reducer cough suppressant nasal decongestant
Purpose - night time pain reliever/fever reducer cough suppressant antihistamine
Product Elements:
Cold and flu multi-symptom relief/cold and flu nighttime relief acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide, and doxylamine succinate daytime cold and flu multi-symptom relief acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan phenylephrine hydrochloride phenylephrine anhydrous citric acid gelatin, unspecified glycerin fd&c red no. 40 fd&c yellow no. 6 sorbitol polyethylene glycol, unspecified povidone, unspecified propylene glycol water shellac titanium dioxide orange to reddish orange q01 nighttime cold and flu relief acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan doxylamine succinate doxylamine d&c yellow no. 10 gelatin, unspecified glycerin fd&c blue no. 1 polyethylene glycol, unspecified povidone, unspecified propylene glycol water shellac sorbitol titanium dioxide q07
Indications and Usage:
Uses - day time temporarily relieves common cold/flu symptoms: nasal congestion cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever
Uses - night time temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever runny nose & sneezing
Warnings:
Warnings - day time liver warning: this product contains acetaminophen. severe liver damage may occur if you take more than 4 doses in 24 hrs, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product sore throat warning: if sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.
Warnings - night time liver warning: this product contains acetaminophen. severe liver damage may occur if you take more than 4 doses in 24 hrs, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product sore throat warning: if sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.
Do Not Use:
Warnings - day time liver warning: this product contains acetaminophen. severe liver damage may occur if you take more than 4 doses in 24 hrs, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product sore throat warning: if sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.
Warnings - night time liver warning: this product contains acetaminophen. severe liver damage may occur if you take more than 4 doses in 24 hrs, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product sore throat warning: if sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.
When Using:
When using this product - night time do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, & tranquilizers may increase drowsiness
Dosage and Administration:
Directions - day time take only as directed â see overdose warning do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 2 capsules with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use when using other daytime or nighttime products, carefully read each label to ensure correct dosing
Directions - night time take only as directed â see overdose warning do not exceed 4 doses per 24 hours adults & children 12 yrs & over 2 capsules with water every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use when using other daytime or nighttime products, carefully read each label to ensure correct dosing
Stop Use:
Stop use and ask a doctor if - night time pain 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 rash or headache that lasts. these could be signs of a serious condition.
Package Label Principal Display Panel:
Package label-principal display panel-48 capsule carton aurohealth ndc 58602-770-54 daytime nighttime compare to the active ingredients compare to the active ingredients in vicks ® dayquil ® cold & flu in vicks ® nyquil ® cold & flu multi-symptom relief liquicaps ®* nighttime relief liquicaps ®* daytime relief nightt ime relief cold & flu cold & flu acetaminophen, acetaminophen, dextromethorphan hbr and dextromethorphan hbr, phenylephrine hcl capsules doxylamine succinate capsules 325 mg/10 mg/5 mg 325 mg/15 mg/6.25 mg ⢠aches, fever &sore throat ⢠aches, fever & sore throat ⢠nasal congestion ⢠sneezing, runny nose ⢠cough ⢠cough 32 capsules 16 capsules package label-principal display panel - 48 capsule bottle
Further Questions:
Questions or comments? call 1-855-274-4122 distributed by: aurohealth llc 2572 brunswick pike lawrenceville, nj 08648