Cough And Cold
FDA Label NDC 45014-151

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 Cough And Cold (NDC 45014-151). 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, directions, other information, inactive ingredients, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Uses

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

Do Not Use

  • to sedate a child or 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 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.

Ask A Doctor Before Use If The Child Has

  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a 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

When Using This Product

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

Directions

  • do not take more than 4 doses in any 24-hour period
  • 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
    • agedose
    under 6 yearsdo not use
    6 to under 12 years1-2 tsp. (5-10 mL) every 6 hours

Other Information

  • each teaspoon contains: sodium 2 mg
  • store at 20°-25°C (68°-77°F)

Inactive Ingredients

artificial flavor, citric acid, FD&C red #40, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose.

Questions?

877-434-2036

Principal Display Panel - 118 Ml Carton

CHILDREN'S
ACCUDIAL

ROTATING DOSING LABEL

Cough & Cold
Long-Acting

ACCURATE DOSING
BY WEIGHT

Chlorpheniramine Maleate
(Antihistamine)

Dextromethorphan HBr
(Cough Suppressant)

RELIEVES
Cough: Up to 8 Hours
Runny Nose

For Ages 6 to under 12

Compares to Children's
Robitussin® Cough &
Cold Long-Acting.

FRUIT
PUNCH
FLAVOR

4 FL. OZ.
(118 mL)
NDC 45014-151-04

Principal Display Panel (118 mL Carton)

Principal Display Panel (118 mL Carton)

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