Nitetime Cough
FDA Label NDC 71027-041

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kingston Pharma Llc for the product Nitetime Cough (NDC 71027-041). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active Ingredient (in each 15 mL = 1 tablespoon):
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine Succinate 6.25 mg

Otc - Purpose

Purpose:
Pain reliever/fever reducer
Cough suppressant
Antihistamine

Indications & Usage

Uses

  • Temporarily relieves these common cold/flu symptoms
    • Cough due to minor throat and bronchial irritation
    • Runny nose and sneezing
    • Minor aches and pains
    • Headache
    • Sore throat
    • Fever

Warnings

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult/child takes

  • More than 4 doses in 24 hours, which is the maximum daily amount for this product.
  • With other drugs containing acetaminophen.
  • Adult has 3 or more alcoholic drinks every day while using this product.
  • 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.

Otc - Do Not Use

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.
  • To make a child sleep.
  • TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL ON THE BOTTLE IS BROKEN OR MISSING.

Otc - Ask Doctor

Ask a doctor before use if you have

  • Glaucoma
  • Liver disease
  • Heart disease
  • High blood pressure
  • Thyroid disease
  • Diabetes
  • Trouble urinating due to an enlarged prostate gland
  • Persistent or chronic cough such as occurs with smoking, asthma or emphysema
  • Cough that occurs with too much phlegm (mucus)
  • A sodium restricted diet
  • Ask a doctor or pharmacist before use if you are

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

Otc - When Using

When using this product

  • Do not exceed recommended dosage
  • Excitability may occur especially in children
  • Marked drowsiness may occur
  • Avoid alcoholic drinks
  • Alcohol, sedatives and tranquilizers may increase drowsiness
  • Be careful when driving a motor vehicle or operating machinery
  • Stop use and ask doctor if

    • Cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts.
    • These could be signs of a serious condition

Otc - Keep Out Of Reach Of Children

Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison control center right away.

Otc - Pregnancy Or Breast Feeding

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

Dosage & Administration

Directions:

  • Do not take more than directed.
  • Use enclosed dosing cup.
  • Do not take more than 4 doses in 24-hours.
  • Adults and children 12 years and over: take 2 tablespoons (TBSP) or 30 mL every 6 hours.
  • Children 4 to under 12 years: ask a doctor
  • Children under 4 years: do not use
  • When using other Daytime or Nite time products, carefully read each label to insure correct dosing

Storage And Handling

Other information

  • Store between 15-30 degree Celsius (59-86 degree Fahrenheit)
  • Each tablespoon contains: Sodium 46mg

Inactive Ingredient

Inactive ingredients: Alcohol, Anhydrous citric acid, FD&C blue 1, FD&C red 40, flavor, High fructose corn syrup, Polyethylene glycol, Propylene glycol, Saccharin sodium, Sodium citrate and Purified Water.

How Supplied

(packs: 4oz, 6oz, 10oz & 12oz) Kingston NDC# 71027-041-06

Manufactured by: Kingston Pharma LLC
5 County Route 42
Massena, NY 13662

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