Topcare Kit
FDA Label NDC 76162-559

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates, Llc for the product Topcare (NDC 76162-559). 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 active ingredients (in each packet), purposes, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Packet)

Acetaminophen 1000 mg

Dextromethorphan HBr 30 mg

Acetaminophen 1000 mg

Chlorpheniramine maleate 4 mg

Dextromethorphan HBr 30 mg

Purposes

Pain reliever/Fever reducer

Cough suppressant

Pain reliever/Fever reducer

Antihistamine

Cough suppressant

Uses

  • temporarily relieves these symptoms due to a common cold or flu:
    • headache
    • minor aches and pains
    • cough due to minor throat and bronchial irritation
    • minor sore throat pain
    • temporarily reduces fever
      • temporarily relieves these symptoms due to a common cold or flu:
        • headache
        • minor aches and pains
        • cough due to minor throat and bronchial irritation
        • minor sore throat pain
        • runny nose
        • temporarily reduces fever

Warnings

Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

    • Allergy alert:Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash
    • 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.

      Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take

      • more than 4,000 mg of acetaminophen in 24 hours
      • with other drugs containing acetaminophen
      • 3 or more alcoholic drinks every day while using this product

        • Allergy alert:Acetaminophen may cause severe skin reactions. Symptoms may include:

        • skin reddening
        • blisters
        • rash

          • 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

  • in a child under 12 years of age
  • if you are allergic to acetaminophen
  • 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.
    • in a child under 12 years of age
    • if you are allergic to acetaminophen
    • 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 a MAO, ask a doctor or pharmacist before taking this product.

Ask A Doctor Before Use If You Have

  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
    • liver disease
    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem such as emphysema or chronic bronchitis
    • cough that occurs with too much phlegm (mucus)
    • cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema

Ask A Doctor Or Pharmacist Before Use If You Are

  • taking the blood thinning drug warfarin
    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers

When Using This Product

  • do not exceed recommended dosage.
    • avoid alcoholic drinks
    • marked drowsiness may occur
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

Stop Use And Ask A Doctor If

  • 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.
    • 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 professional before use.

ask a health professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • do not use more than directed
  • take every 6 hours, while symptoms persist. Do not take more than 3 packets in 24 hours unless directed by a doctor.
    • Age
    • Dose
    • adults and children 12 years of age and over
    • one packet
    • children under 12 years of age
    • do not use
    • dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume the entire drink within 10-15 minutes.
    • if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.
      • do not use more than directed
      • take every 6 hours, while symptoms persist. Do not take more than 3 packets in 24 hours unless directed by a doctor.
        • Age
        • Dose
        • adults and children 12 years of age and over
        • one packet
        • children under 12 years of age
        • do not use
        • dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
        • if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat

Other Information

  • each packet contains: potassium 6 mg
  • store at room temperature. Protect from excessive heat and moisture.
    • each packet contains: potassium 6 mg
    • store at room temperature. Protect from excessive heat and moisture.

Inactive Ingredients

anhydrous citric acid, caramel, flavor, maltodextrin, potassium chloride, silica, sucralose, sucrose.

anhydrous citric acid, caramel, flavor, maltodextrin, potassium chloride, silica, sucralose, sucrose.

Questions Or Comments?

1-866-467-2748

1-866-467-2748

Other Safety Information

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.

DO NOT TAKE MORE THAN 3 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.

DO NOT TAKE A DOSE OF THE NIGHTTIME PRODUCT SOONER THAN 4 HOURS AFTER THE LAST DOSE OF THE DAYTIME PRODUCT UNLESS DIRECTED BY A DOCTOR.

TAMPER-EVIDENT: DO NOT USE INNER SEALED PACKET IF TORN OR BROKEN.

Distributed by:

Principal Display Panel

*Compare to the active ingredients in Theraflu Multi-Symptom Flu Relief Max Strength** Daytime & Nighttime.

NDC 76162-559-12

FLU RELIEF

MAX STRENGTH**

6 x DAYTIME

AcetaminophenPain Reliever/Fever Reducer

Dextromethorphan HBrCough Suppressant

6 x NIGHTTIME

AcetaminophenPain Reliever/Fever Reducer

Chlorpheniramine MaleateAntihistamine

Dextromethorphan HBrCough Suppressant

Hot liquid therapy that relieves:

  • Fever
  • Body ache
  • Headache
  • Sore throat pain
  • Cough
  • Runny nose (Nighttime only)

    • Free from synthetic dyes

    6 DAYTIME PACKETS

    6 NIGHTTIME PACKETS

    12 TOTAL PACKETS

    Honey Lemon

    Natural & Artificial Flavored

    Topco Flu Relief Daytime And Nighttime Powder 12ct (Image 01)

    Topco Flu Relief Daytime And Nighttime Powder 12ct (Image 01)

* Please review the disclaimer below.