NDC 36800-562 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

NDC Product Code 36800-562

NDC Code: 36800-562

Proprietary Name: Topcare Health Non Drowsy Daytime Cold And Flu Relief And Nighttime Cold And Flu Relief Day And Night Combo Pack What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Acetaminophen ,dextromethorphan Hydrobromide And Phenylephrine Hcl ,acetaminophen,dextromethorphan Hbr,doxylamine Succinate 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.


Code Structure
  • 36800 - Topcare Health
    • 36800-562 - Topcare Health Non Drowsy Daytime Cold And Flu Relief And Nighttime Cold And Flu Relief

NDC 36800-562-08

Package Description: 1 KIT in 1 KIT * 4 CUP in 1 KIT > 1 POWDER, FOR SOLUTION in 1 CUP * 4 CUP in 1 KIT > 1 POWDER, FOR SOLUTION in 1 CUP

NDC Product Information

Topcare Health Non Drowsy Daytime Cold And Flu Relief And Nighttime Cold And Flu Relief Day And Night Combo Pack with NDC 36800-562 is a a human over the counter drug product labeled by Topcare Health. The generic name of Topcare Health Non Drowsy Daytime Cold And Flu Relief And Nighttime Cold And Flu Relief Day And Night Combo Pack is acetaminophen ,dextromethorphan hydrobromide and phenylephrine hcl ,acetaminophen,dextromethorphan hbr,doxylamine succinate. The product's dosage form is kit and is administered via form.

Labeler Name: Topcare Health

Dosage Form: Kit - A packaged collection of related material.

Product Type: Human Otc Drug 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.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • ISOMALT (UNII: S870P55O2W)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • ISOMALT (UNII: S870P55O2W)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Topcare Health
Labeler Code: 36800
FDA Application Number: part341 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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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.

Start Marketing Date: 03-06-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Topcare Health Non Drowsy Daytime Cold And Flu Relief And Nighttime Cold And Flu Relief Day And Night Combo Pack Product Label Images

Topcare Health Non Drowsy Daytime Cold And Flu Relief And Nighttime Cold And Flu Relief Day And Night Combo Pack Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts Daytime Cold & Flu Relief

DaytimeIn 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.NighttimeIn 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.

Otc - Purpose

Active ingredients (in each single serve cup)PurposesAcetaminophen 650 mgPain reliever/fever reducerDextromethorphan HBr 20 mgCough suppressantPhenylephrine HCl 10 mgNasal decongestantDrug Facts Nighttime Cold & Flu ReliefActive ingredients (in each single serve cup)PurposesAcetaminophen 650 mgPain reliever/Fever reducerDextromethorphan HBr 30 mgCough suppressantDoxylamine succinate 12.5 mgAntihistamine

Uses

  • Daytimetemporarily 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

Liver Warning:

  • DaytimeThis 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 productAllergy Alert: Acetaminophen may cause severe skin reaction. Symptom may include: •Skin reddening •Blisters •RashIf a skin reaction occurs, stop use and seek medical help right away. NighttimeThis 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 productAllergy Alert: Acetaminophen may cause severe skin reaction. Symptom may include: •Skin reddening •Blisters •RashIf a skin reaction occurs, stop use and seek medical help right away.

Sore Throat Warning:

  • DaytimeIf 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. NighttimeIf 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 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 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 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

  • 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 •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 prostate gland

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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health care professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

  • Daytime •take only as directed - see Overdose warning •do not exceed 4 doses per 24 hoursadults & children 12yrs & overone cup every 4 hrschildren under 12yrsdo not use •place single–serve 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 •take only as directed - see Overdose warning •do not exceed 4 doses per 24 hoursadults & children 12yrs & overone cup every 6 hrschildren under 12yrsdo not use •place single-serve cup in any 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

Other Information

  • Daytime •store at room temperature   Nighttime

Inactive Ingredients

Daytime citric acid, FD&C Red No. 40, flavors, isomalt, silica, sucraloseNighttime citric acid, FD&C Yellow No.6, flavors, isomalt, silica, sucralose

* Please review the disclaimer below.

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