Nite Time Cold and Cough

Accudial Pharmaceutical, Inc.

Nite Time Cold & Cough

FULL PRESCRIBING INFORMATION: CONTENTS*

• Nite Time Cold and Cough Uses
• Warnings
  • When using this product
  • Overdose warning
• Nite Time Cold and Cough Other information
• Directions
• Inactive ingredients
• Questions?
• PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Nite Time Cold and Cough 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.

Warnings

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.

Ask a pharmacist before use if the child is taking sedatives or tranquilizers.

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.

Consult your pharmacist or health care provider for any appropriate, additional dosage delivery device necessary for use when a physician recommends a dose that is different than the doses that appear on the dosage delivery device that accompanies this product.

Keep out of reach of children.

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Prompt medical attention is critical, even if you do not notice any signs or symptoms.

Nite Time Cold and Cough Other information

• each teaspoon contains: sodium 9 mg
• store between 20°-25°C (68°-77°F)
• tamper evident: do not use if foil seal over the mouth of the bottle is torn, broken, or missing.

Directions

• may be given every 4 hours
• do not use more than 6 times in 24 hours
• use only enclosed dosing cup to dose this product. Do not use any other dosing device.

Inactive ingredients

artificial flavor, benzoic acid, citric acid, EDTA disodium dihydrate, FD&C blue #1, FD&C red #40, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol.

Questions?

877-434-2036

Distributed by: AccuDial® Pharmaceutical, Inc.
Palm Beach Gardens, FL 33408

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

ACCU DIAL _®
Children's
Nite Time
Cold and Cough

Diphenhydramine
(Antihistamine/Cough Suppressant)

Phenylephrine HCl (Nasal Decongestant)

Relieves Cough • Runny Nose
Stuffy Nose • Itchy Throat

Earth-Friendly
Package!

For Ages 6 yrs to under 12 yrs

Tamper Evident

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

GRAPE
FLAVOR

NDC 45014-159-04
4 FL. OZ. (118 mL)