Topcare Nite Time Cold And Flu Relief Solution
FDA Label NDC 36800-459

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 Nite Time Cold And Flu Relief (NDC 36800-459). 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 nitetime cold & fluactive ingredients (in each 30 ml), purpose, 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

Nitetime Cold & Fluactive Ingredients (In Each 30 Ml)

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever
  • runny nose and sneezing
    • temporarily relieves common cold/flu symptoms:
    • nasal congestion
    • cough due to minor throat and bronchial irritation
    • sore throat
    • headache
    • minor aches and pains
    • 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

      • adult takes more than 4,000 mg of acetaminophen in 24 hours
      • child takes more than 5 doses in 24 hours
      • taken with other drugs containing acetaminophen
      • adult has 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

  • 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.
  • if you have ever had an allergic reaction to this product or any of its ingredients
    • 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.
    • if you have ever had an allergic reaction to this product or any of its ingredients

Ask A Doctor Before Use If You Have

  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema
  • a sodium-restricted diet
    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland
    • cough that occurs with too much phlegm (mucus)
    • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Ask A Doctor Or Pharmacist Before Use If You Are

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

    • taking the blood thinning drug warfarin

When Using This Product

  • 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, and tranquilizers may increase drowsiness

    • do not use more than directed

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.
    • 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.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

ask a health professional before use.

Keep Out Of Reach Of Children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • take only as directed – see Overdose warning
  • only use the dose cup provided
  • do not exceed 4 doses per 24 hrs

    • adults & children 12 yrs & over

    30 mL every 6 hrs

    children 4 to under 12 yrs

    ask a doctor

    children under 4 yrs

    do not use

    • take only as directed – see Overdose warning
    • only use the dose cup provided
    • do not exceed 4 doses per 24 hrs

      • adults & children 12 yrs & over

      30 mL every 4 hrs

      children 6 to under 12 yrs

      15 mL every 4 hrs

      children 4 to under 6 yrs

      ask a doctor

      children under 4 yrs

      do not use

Other Information

  • each 30 mL dose cup contains: sodium 39 mg
  • store at 20-25°C (68-77°F)
    • each 15 mL contains: sodium 7 mg
    • store at 20-25°C (68-77°F)

Inactive Ingredients

alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

butylated hydroxyanisole, edetate disodium, FD&C yellow no. 6, flavor, glycerin, menthol, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum

Questions Or Comments?

1-888-423-0139

1-888-423-0139

Daytime Cold & Fluactive Ingredients (In Each 15 Ml)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Package/Label Principal Display Panel

SPECIAL VALUE! COMBINATION PACK

SEE NEW WARNINGS

COMPARE TO VICKS® DAYQUIL® ACTIVE INGREDIENTS

MULTI-SYMPTOM RELIEF

Day Time

Cold & Flu Relief

OUR PHARMACISTS RECOMMEND

PAIN RELIVER – FEVER REDUCER – ACETAMINOPHEN

COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr

NASAL DECONGESTANT – PHENYLEPHRINE HCl

Headache, Fever, Sore Throat, Minor Aches & Pains

Nasal Congestion

Cough

Alcohol Free

Antihistamine Free

Non-Drowsy

12 FL OZ (355 mL)

ORIGINAL FLAVOR

SEE NEW WARNINGS

COMPARE TO VICKS® NYQUIL® ACTIVE INGREDIENTS

MULTI-SYMPTOM RELIEF

Nite Time

Cold & Flu Relief

OUR PHARMACISTS RECOMMEND

PAIN RELIEVER – FEVER REDUCER – ACETAMINOPHEN

COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr

ANTIHISTAMINE – DOXYLAMINE SUCCINATE

Headache, Fever, Sore Throat, Minor Aches & Pains

Sneezing, Runny Nose

Cough

12 FL OZ (355 mL)

CHERRY FLAVOR

Day Time Nite Time Cold & Flu Relief Image 1 (7330288c6 Image 1)

Day Time Nite Time Cold & Flu Relief Image 1 (7330288c6 Image 1)

Day Time Nite Time Cold & Flu Relief Image 2 (7330288c6 Image 2)

Day Time Nite Time Cold & Flu Relief Image 2 (7330288c6 Image 2)

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