Night Time Cough And Cold Relief
FDA Label NDC 68016-137

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Consortium, Llc for the product Night Time Cough And Cold Relief (NDC 68016-137). 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, purpose, keep out of reach of children, uses, warnings, 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

Drug Facts

Active ingredients
(in each 5 mL tsp)

Diphenhydramine HCL, USP 6.25 mg

Phenylephrine HCL, USP 2.5.mg

Purpose

Antihistamine / Cough suppressant

Nasal decongestant

Keep Out Of Reach Of Children

Keep out of reach of children.

 In case of overdose, get medical help or contact a Poison Control center right away.

Uses

  • temporarily controls cough due to minor throat and bronchial irritation and relieves nasal congestion as may occur with a cold
  • temporarily relieves the following symptoms due to hay fever or other upper respiratory allergies:
    • sneezing
    • runny nose
    • itchy, watery eyes
    • itchy nose or throat

Warnings

Do not use

  • with any other product containing diphenhydramine, even one used on the skin
  • to make a child sleepy
  • 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 two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or a pharmacist before taking this product.

Ask A Doctor Before Use If You Have

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

Ask A Doctor Or Pharmacist Before Use If You Are

  • taking sedatives or tranquilizers.

When Using This Product

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

Stop Use And Ask A Doctor If

  • nervousness, dizziness or sleeplessness occur
  • symptoms do not get better within 7 days or occur with fever
  • cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache
  • These could be signs of a serious condition.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Directions

  • do not take more than directed
  • do not take more than 6 doses in any 24-hour period
  • use dose cup or teaspoon


Other Information

  • each tablespoonful contains: sodium 3 mg
  • store between 20-25° C (68-77° F)
  • do not refrigerate
  • dosage cup provided
  • Keep carton for full directions for use

Inactive Ingredients

acesulfame potassium, anhydrous citric acid, edetate disodium, FD and C Blue # 1, FD and C Red # 40, flavor, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

Questions?

Call weekdays from 9:30 AM to 4:30 PM EST 1-877-798-5944

Product Label

NDC68016-137-00

*COMPARE TO THE ACTIVE INGREDIENTS IN DELSYM® NIGHT TIME COUGH and COLD

Premier Value®

NIGHT TIME
COUGH and COLD RELIEF

Diphenhydramine HCL .......................Antihistamine/Cough Suppressant

Phenylephrine HCL ...........................Nasal Decongestant

  • Sneezing
  • Runny Nose
  • Cough
  • Nasal Congestion



    • Grape Flavored Liquid
    4 FL OZ (120 mL)

    INDEPENDENTLY TESTED SATISFACTION GUARANTEED PV

    DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

    *This product is not manufactured or distributed by Reckitt Benckiser Inc. distributor of Children’s Mucinex® Multisymptom Cold
    If for Any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

    DISTRIBUTED BY
    CHAIN DRUG CONSORTIUM
    3301 NW BOCA RATON BLVD
    SUITE 101, BOCA RATON, FL 33431
    BX-009

* Please review the disclaimer below.