Assured Childrens Cold and Cough

Bio-Pharm, Inc.

ASSURED® Children's Cold & Cough

FULL PRESCRIBING INFORMATION: CONTENTS*

• Assured Childrens Cold and Cough Uses
• Warnings
  • Do not use
  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use if you are
  • When using this product
  • Stop use and ask a doctor if
• Directions
• Assured Childrens Cold and Cough Other information
• Inactive Ingredients
• PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Assured Childrens Cold and Cough Uses

• temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies
• temporarily relieves these symptoms due to hay fever (allergic rhinitis):
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of nose or throat
• temporarily restores freer breathing through the nose

Warnings

Do not use

• to sedate a child or 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 MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate
• glaucoma
• cough that occurs with too much phlegm (mucus)
• a breathing problem or persistent or chronic cough that lasts such as with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you are

• taking any other oral nasal decongestant or stimulant
• taking sedatives or tranquilizers

When using this product

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

Stop use and ask a doctor if

• you get nervous, dizzy or sleepless
• symptoms do not get better within 7 days or are accompanied by fever
• 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 (1-800-222-1222) right away.

Directions

• do not take more than 6 doses in any 24-hour

Assured Childrens Cold and Cough Other information

• each TSP (5mL) contains: sodium 3 mg
• TAMPER-EVIDENT: Do not use if foil seal over the mouth of the bottle is torn, broken or missing
• Store at 20°-25°C (68°-77°F)
• dosage cup provided

Inactive Ingredients

citric acid anhydrous, FD&C blue#1, FD&C red #40, glycerin, flavor, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium saccharin, sorbitol

Manufactured by:
Bio-Pharm, Inc.
Levittown, PA 19057

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

NDC 59741-193-06

ASSURED®

See New Warning & Dosing Directions

Children's
Cold & Cough

Antihistamine: Brompheniramine Maleate
Cough Suppressant: Dextromethorphan HBr
Nasal Decongestant: Phenylephrine HCl

Relieves:
• Stuffy Nose • Runny Nose • Sneezing
• Coughing • Itchy, Watery Eyes

Alcohol-Free

Grape
Flavor

4 FL OZ (118 mL)