Night-time Liquid
FDA Label NDC 53943-508

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Discount Drug Mart for the product Night-time (NDC 53943-508). 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 drug factsactive ingredients (in each 30 ml dose cup), purpose, keep out of reach of children, uses, warnings, do not use, ask a doctor befor use if you have, ask a doctor or pharmacist before use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Factsactive Ingredients (In Each 30 Ml Dose Cup)

Dextromethorphan HBr 30 mg

Doxylamine Succinate 12.5 mg

Purpose

Cough suppressant

Antihistamine

Keep Out Of Reach Of Children

Keep out of reach of children.

Uses

temporarily relieves cold symptoms:

  • runny nose and sneezing
  • cough

Warnings

DO NOT USE IF IMPRINTED SHRINK BRAND IS MISSING OR BROKEN

Failure to follow these warnings could result in serious consequences.

Do Not Use

  • if you are now taking a prescription monamine 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 sleepy

Ask A Doctor Befor Use If You Have

  • a sodium restricted diet
  • 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 taking sedatives or tranquilizers

When Using This Product

  • do not use more than directed
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness

Stop Use And Ask A 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.

If Pregnant Or Breast Feeding,

ask a health professionalbefore use.

Directions

  • Use dose cup or tablespoon (TBSP)
  • do not exceed 4 doses per 24 hours
  • When using Day Time and Night Time products, carefully read each label to ensure
    •  adults and children 12 years and over 30 mL (2 TBSP) every 6 hours
     children 4 to under 12 years ask a doctor
     children under 4 years do not use

Other Information

  • each 30 mL dose cup contains: sodium 45 mg
  • store at room temperature

Inactive Ingredients

citric acid, FD and C Blue No. 1, FD and C Red No. 40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose

Questions ?

Call weekdays from 9:30 am to 4:30 pm EST.

1-877-798-5944.

Discount Drug Martfood Faircherrynight-Timecough Refief Product Label

*COMPARE TO THE INGREDIENTS IN VICKS® NYQUIL® COUGH

DISCOUNT

drug mart

FOOD FAIR

Cherry

Night-Time

COUGH RELIEF

Dextromethorphan HBr ..... Cough Suppressant

Doxylamine Succiate ......... Antihistamine

  • Cough
  • Sneezing
  • Runny Nose

    • 12 FL OZ (354 mL)

    * This product is not manufactured or distributed by Proctor and Gamble owner of the registered trademark Vicks® Nyquil® Cough

    LR-067

    SATISFACTION GUARANTEED

    IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO THE STORE WHERE PURCHASED. IF UNABLE TO RETURN TO THE STORE, SEND REASON FOR DISSATISFACTION ,  NAME, ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE MEDINNA, OHIO 44256

* Please review the disclaimer below.