Topcare Health Non Drowsy Daytime Cold And Flu Relief And Nighttime Cold And Flu Relief
FDA Label NDC 36800-562

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topcare Health for the product Topcare Health Non Drowsy Daytime Cold And Flu Relief And Nighttime Cold And Flu Relief (NDC 36800-562). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, liver warning:, sore throat warning:, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts Daytime Cold & Flu Relief

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.

Otc - 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

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

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
    •  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 hours

    • adults & children 12yrs & over

    one cup every 4 hrs

    children under 12yrs

    do 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 hours

          • adults & children 12yrs & over

          one cup every 6 hrs

          children under 12yrs

          do 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, sucralose

Nighttime

citric acid, FD&C Yellow No.6, flavors, isomalt, silica, sucralose

Questions Or Comments?

Daytime

1-866-467-2748

Nighttime

1-866-467-2748

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
    •  Naturally and Artificially Flavored
    •  Alcohol free

      • 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.

      †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

      [email protected]

      www.topcarebrand.com

      QualityGuarantee

      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 –HOUR 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 (Nyquil 01)

      Topcare Daytime & Nitetime Acetaminophen (Nyquil 01)

* Please review the disclaimer below.