Nite Time Cold And Cough
FDA Label NDC 45014-154

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Accudial Pharmaceutical, Inc. for the product Nite Time Cold And Cough (NDC 45014-154). 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 uses, do not use, ask a doctor before use if the child has, when using this product, stop use and ask a doctor if, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Uses

  • temporarily relieves
  • sneezing
  • itchy nose or throat
  • runny nose
  • itchy, watery eyes due to hay fever
  • nasal and sinus congestion
  • cough due to minor throat and bronchial irritation as may occur with a cold

Do Not Use

  • in a child under 6 years of age
  • in a child who is 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 the child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
  • with any other product containing diphenhydramine, even one used on skin
  • for the purpose of making your child sleepy

Ask A Doctor Before Use If The Child Has

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

When Using This Product

  • do not exceed recommended dosage
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children

Stop Use And Ask A Doctor If

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

Directions

  • may be given every 4 hours. Do not give more than 6 doses in 24 hours unless directed by a doctor.
  • to find right dose, use rotating bottle label to dose by weight; otherwise, use chart below to dose by age.
  • specifically designed for use with enclosed dosing spoon. Use only enclosed dosing spoon to dose this product. Do not use any other dosing device.
    • children under 6 years of agedo not use
    children 6 to under 12 years of age1-2 tsp. (5-10 mL)

Other Information

  • each teaspoonful contains: sodium 4 mg
  • store at controlled room temperature 20°-25°C (68°-77°F)

Inactive Ingredients

artificial flavor, benzoic acid, citric acid, disodium edetate, FD&C blue no. 1, FD&C red no. 40, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol.

Questions?

877-434-2036

Principal Display Panel - 118 Ml Carton

CHILDREN'S
ACCUDIAL

ROTATING DOSING LABEL

Nite Time
Cold & Cough

ACCURATE DOSING
BY WEIGHT

Diphenhydramine HCl
(Antihistamine/Cough Suppressant

Phenylephrine HCl
(Nasal Decongestant)

Cough Relief
Runny, Stuffy Nose
Itchy Throat

For Ages 6 to under 12

Compares to Children's
Triaminic® Night Time
Cold & Cough.

GRAPE
FLAVOR

4 FL. OZ.
(118 mL)
NDC 45014-154-04

Principal Display Panel (118 mL Carton)

Principal Display Panel (118 mL Carton)

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