Childrens Night Time
FDA Label NDC 68016-143

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 Childrens Night Time (NDC 68016-143). 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 the child has, ask a doctor or pharmacist before use if the child is, 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 child’s prescription drug contains an MAOI, ask a doctor or a pharmacist before taking this product.

Ask A Doctor Before Use If The Child Has

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • a breathing problem such as chronic bronchitis
  • persistent or chronic cough such as occurs with asthma
  • cough that occurs with too much phlegm (mucus)

Ask A Doctor Or Pharmacist Before Use If The Child Is

  • taking sedatives or tranquilizers.

When Using This Product

  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness

Stop Use And Ask A Doctor If

  • nervousness, dizziness or sleeplessness occus
  • 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.

Directions

  • do not use more than directed
  • do not take more than 6 doses in any 24-hour period
  • use dosage cup or teaspoon
    • Aptapharmapv Childrensnighttimecc2 Label (Aptapharmapv Childrensnighttimecc2)

    Aptapharmapv Childrensnighttimecc2 Label (Aptapharmapv Childrensnighttimecc2)

Other Information

  • each teaspoonful 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, citric acid anhydrous, edeate disodium, FD and C blue #1, FD and C red # 40, flavors, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

Questions?

Call weekdays from 9:30 AM to 4:30 PM EST at

 1-877-798-5944

Product Label

NDC 68016-143-00

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

Premier Value®
Children's Night Time

COUGH and COLD RELIEF

Diphenhydramine HCL..........Antihistamine / Cough Suppressant
Phenylephrine HCL ............ Nasal Decongestant

Sneezing
Runny Nose
Cough
Stuffy Nose


Grape Flavored Liquid
4 FL OZ (118mL)

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 Delsym® Children's Night Time Cough and Cold
If for Any reason you are not satisfied with this product, lease 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-008

Aptapharmapv Childrensnighttimecc Label (Aptapharmapv Childrensnighttimecc)

Aptapharmapv Childrensnighttimecc Label (Aptapharmapv Childrensnighttimecc)

* Please review the disclaimer below.