Topcare Health Non Drowsy Daytime Cold And Flu Relief And Nighttime Cold And Flu Relief Day And Night Combo Pack
Acetaminophen ,dextromethorphan Hydrobromide And Phenylephrine Hcl ,acetaminophen,dextromethorphan Hbr,doxylamine Succinate
Topcare Health
Human Otc Drug
NDC 36800-562Topcare Health Non Drowsy Daytime Cold And Flu Relief And Nighttime Cold And Flu Relief Day And Night Combo Pack also known as Acetaminophen ,dextromethorphan Hydrobromide And Phenylephrine Hcl ,acetaminophen,dextromethorphan Hbr,doxylamine Succinate is a human otc drug labeled by 'Topcare Health'. National Drug Code (NDC) number for Topcare Health Non Drowsy Daytime Cold And Flu Relief And Nighttime Cold And Flu Relief Day And Night Combo Pack is 36800-562. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Topcare Health Non Drowsy Daytime Cold And Flu Relief And Nighttime Cold And Flu Relief Day And Night Combo Pack drug includes . The currest status of Topcare Health Non Drowsy Daytime Cold And Flu Relief And Nighttime Cold And Flu Relief Day And Night Combo Pack drug is Active.
Drug Information:
| Drug NDC: | 36800-562 |
| 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: | Topcare Health Non Drowsy Daytime Cold And Flu Relief And Nighttime Cold And Flu Relief Day And Night Combo Pack |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Topcare Health Non Drowsy Daytime Cold And Flu Relief And Nighttime Cold And Flu Relief |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Day and Night Combo Pack |
| 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 ,dextromethorphan Hydrobromide And Phenylephrine Hcl ,acetaminophen,dextromethorphan Hbr,doxylamine Succinate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Topcare Health |
| 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: | 06 Mar, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 05 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: | TopCare Health
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1659967
1805288
2119242
|
| 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 |
|---|
| 36800-562-08 | 1 KIT in 1 KIT (36800-562-08) * 4 CUP in 1 KIT / 1 POWDER, FOR SOLUTION in 1 CUP * 4 CUP in 1 KIT / 1 POWDER, FOR SOLUTION in 1 CUP | 06 Mar, 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:
Active ingredients (in each single serve cup) purposes acetaminophen 650 mg pain reliever/fever reducer dextromethorphan hbr 20 mg cough suppressant phenylephrine hcl 10 mg nasal decongestant drug facts nighttime cold & flu relief active ingredients (in each single serve cup) purposes acetaminophen 650 mg pain reliever/fever reducer dextromethorphan hbr 30 mg cough suppressant doxylamine succinate 12.5 mg antihistamine
Product Elements:
Topcare health non drowsy daytime cold and flu relief and nighttime cold and flu relief day and night combo pack acetaminophen ,dextromethorphan hydrobromide and phenylephrine hcl ,acetaminophen,dextromethorphan hbr,doxylamine succinate topcare health daytime cold and flu relief daytime acetaminophen ,dextromethorphan hydrobromide and phenylephrine hcl acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan phenylephrine hydrochloride phenylephrine anhydrous citric acid fd&c red no. 40 isomalt silicon dioxide sucralose topcare health nighttime cold and flu relief nighttime acetaminophen,dextromethorphan hbr,doxylamine succinate acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan doxylamine succinate doxylamine anhydrous citric acid fd&c yellow no. 6 isomalt silicon dioxide sucralose
Indications and Usage:
Uses daytime temporarily relieves common cold/flu symptoms: ⢠nasal congestion ⢠cough due to minor throat & bronchial irritation ⢠sore throat ⢠headache ⢠minor aches & pains ⢠fever nighttime 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 liver warning: daytime this product contains acetaminophen. severe liver damage may occur if you take ⢠more than 4 doses in 24 hours, which is the maximum daily amount for this product ⢠with other drugs containing acetaminophen ⢠3 or more alcoholic drinks daily while using this product allergy alert: acetaminophen may cause severe skin reaction. symptom may include: ⢠skin reddening ⢠blisters ⢠rash if a skin reaction occurs, stop use and seek medical help right away. nighttime this product contains acetaminophen. severe liver damage may occur if you take ⢠more than 4 doses in 24 hours, which is the maximum daily amount for this product ⢠with other drugs containing acetaminophen ⢠3 or more alcoholic drinks every day while using this product allergy alert: acetaminophen may cause severe skin reaction. symptom may include: ⢠skin reddening ⢠blisters ⢠rash if a skin reaction occurs, stop use and seek medical hel
Read more...p right away. sore throat warning: daytime if sore throat is severe, lasts for more than 2 days, is accompanied with or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. nighttime if sore throat is severe, lasts for more than 2 days, is accompanied with or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. do not use daytime nighttime ⢠with any other products containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ⢠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 drugs. if you do not know if your prescription drug contains an maoi, ask a doctor or pharmacist before taking this product. nighttime ask a doctor before use if you have daytime ⢠liver disease ⢠heart disease ⢠thyroid disease ⢠diabetes ⢠high blood pressure ⢠trouble urinating due to enlarged prostate gland ⢠cough that occurs with too much phlegm (mucus) ⢠persistent or chronic cough such as occurs with smoking, asthma, or emphysema nighttime ask a doctor or pharmacist before use if you are daytime taking the blood thinning drug warfarin. nighttime taking sedatives or tranquilizers taking the blood thinning drug warfarin daytime: when using this product, do not use more than directed. nighttime ⢠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 stop use and ask a doctor if daytime ⢠you get nervous, dizzy or sleepless ⢠pain, nasal congestion or cough gets worse or lasts more than 5 days(children) or 7 days(adults) ⢠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. nighttime ⢠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. if pregnant or breast-feeding , ask a health care professional before use. keep out of reach of children. daytime in case of overdose, get medical help or contact a poison control center right away at 1-800-222-1222. prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. nighttime in case of overdose, get medical help or contact a poison control center right away at 1-800-222-1222. prompt 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: daytime this product contains acetaminophen. severe liver damage may occur if you take ⢠more than 4 doses in 24 hours, which is the maximum daily amount for this product ⢠with other drugs containing acetaminophen ⢠3 or more alcoholic drinks daily while using this product allergy alert: acetaminophen may cause severe skin reaction. symptom may include: ⢠skin reddening ⢠blisters ⢠rash if a skin reaction occurs, stop use and seek medical help right away. nighttime this product contains acetaminophen. severe liver damage may occur if you take ⢠more than 4 doses in 24 hours, which is the maximum daily amount for this product ⢠with other drugs containing acetaminophen ⢠3 or more alcoholic drinks every day while using this product allergy alert: acetaminophen may cause severe skin reaction. symptom may include: ⢠skin reddening ⢠blisters ⢠rash if a skin reaction occurs, stop use and seek medical help right away. sore throat warning: daytime if sore throat is severe, lasts for more than 2 days, is accompanied with or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. nighttime if sore throat is severe, lasts for more than 2 days, is accompanied with or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. do not use daytime nighttime ⢠with any other products containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ⢠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 drugs. if you do not know if your prescription drug contains an maoi, ask a doctor or pharmacist before taking this product. nighttime ask a doctor before use if you have daytime ⢠liver disease ⢠heart disease ⢠thyroid disease ⢠diabetes ⢠high blood pressure ⢠trouble urinating due to enlarged prostate gland ⢠cough that occurs with too much phlegm (mucus) ⢠persistent or chronic cough such as occurs with smoking, asthma, or emphysema nighttime ask a doctor or pharmacist before use if you are daytime taking the blood thinning drug warfarin. nighttime taking sedatives or tranquilizers taking the blood thinning drug warfarin daytime: when using this product, do not use more than directed. nighttime ⢠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 stop use and ask a doctor if daytime ⢠you get nervous, dizzy or sleepless ⢠pain, nasal congestion or cough gets worse or lasts more than 5 days(children) or 7 days(adults) ⢠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. nighttime ⢠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. if pregnant or breast-feeding , ask a health care professional before use. keep out of reach of children. daytime in case of overdose, get medical help or contact a poison control center right away at 1-800-222-1222. prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. nighttime in case of overdose, get medical help or contact a poison control center right away at 1-800-222-1222. prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
When Using:
Daytime: when using this product, do not use more than directed. nighttime ⢠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 daytime ⢠take only as directed - see overdose warning ⢠do not exceed 4 doses per 24 hours adults & children 12yrs & over one cup every 4 hrs children under 12yrs do not use ⢠place singleâserve cup in compatible brewer ⢠use a minimum of 8 oz of water ⢠when finished, the single serve cups are hot and may drip. tilt the cup during removal to avoid dripping. ⢠do not remove the foil seal as the cup will not work properly in any single serve compatible brewer and could result in hot water burns. ⢠flush brewer after use nighttime adults & children 12yrs & over one cup every 6 hrs children under 12yrs do not use ⢠place single-serve cup in any compatible brewerâ ⢠use a minimum of 8 oz of water ⢠when finished, the single serve cups are hot and may drip. tilt the cup during removal to avoid dripping.
Stop Use:
Stop use and ask a doctor if daytime ⢠you get nervous, dizzy or sleepless ⢠pain, nasal congestion or cough gets worse or lasts more than 5 days(children) or 7 days(adults) ⢠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. nighttime ⢠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:
Principal display panel day & night combination pack topcare health ⢠ndc 36800-562-08 compare to the active ingredients in vicks ® dayquil ® cold & flu* non-drowsy daytime cold & flu relief single serve cups compatible with keurig ® k- cup brewers & keurig 2.0 brewing system, realcup® brewers, remington icoffe® express⢠brewers and other single-serve pod machine and personal cup brewers, day time cold & flu pain reliever/fever reducer, acetaminophen cough suppressant dextromethorphan habra nasal decongestant phenylephrine hcl relieves: ⢠headache, fever, sore throat ⢠minor aches & pains ⢠nasal congestion ⢠cough berry flavor infused with menthol & green tea flavors naturally and artificially flavored alcohol free 4 daytime cups compare to the active ingredients in vicks ® nyquil ® cold & flu* nighttime cold & flu relief single serve cups k-cup®/real cup® pod compatible acetaminophen pain reliever/fever reducer dextromethorphan hbr cough suppressant doxylamine succinate antihistamine relieves: ⢠headache, fever, sore throat ⢠minor aches and pains ⢠sneezing, runny nose ⢠cough honey lemon flavor infused chamomile & white tea flavors 4 nighttime cups 8 total single serve cups our single serve cold and flu relief cups are a warm and easy way to feel better fast. just use our cups as you would any other single serve cup in your single serve machine for a great- tasting, flu-relieving drink anytime .whether you need a non- drowsy way to get through a long day ahead ,or you are finally tucking yourself into bed at night, take a moment and toast to relief. *this product is not manufactured or distributed by procter and gamble company, owner of the registered trademark vicks ® dayquil ® cold & flu and vicks ® nyquil ® cold &flu. â compatible with keurig ® k- cup ® brewers & keurig 2.0 brewing systems. this product is not affiliated with keurig, inc. distributed by: topco associates llc elk grove village, il 60007 ©topco rara0219 questions? 1-888-423-0139 topcare@topco.com www.topcarebrand.com quality guarantee this topcare product is laboratory tested to guarantee its highest quality. your total satisfaction is guaranteed. patent pending tamper evident pouch: this package is safety sealed & child resistant. product is packeged in individual sealed pouches. do not use if sealed cup is torn and broken. read all warnings and directions on carton before use .keep carton for reference, do not discard. do not take both products at the same time or take more than 4 doses in any 24 âhour period. do not take a dose of the nighttime product sooner than 4 hours after the last dose of daytime product unless directed by doctor. topcare daytime & nitetime acetaminophen
Further Questions:
Questions or comments? daytime 1-866-467-2748 nighttime 1-866-467-2748