Cough and Cold

Accudial Pharmaceutical, Inc.

Children's ACCUDIAL

FULL PRESCRIBING INFORMATION: CONTENTS*

• Cough and Cold Uses
• Warnings
  • Do not use
  • Ask a doctor before use if the child has
  • When using this product
• Directions
• Cough and Cold Other information
• Inactive ingredients
• Questions?
• PRINCIPAL DISPLAY PANEL - 118 mL Carton

FULL PRESCRIBING INFORMATION

COUGH & COLD LONG-ACTING

Drug Facts

Active ingredient

Purpose

Cough and Cold 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

Warnings

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

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
• 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

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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

Cough and Cold 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