Assured Night time Cold and Cough

Bio-Pharm, Inc.

ASSURED ® Night Time Cold & Cough

FULL PRESCRIBING INFORMATION: CONTENTS*

• Assured Night time Cold and Cough Uses
• Warnings
  • Do not use
  • Ask a doctor before use if the child has
  • Ask a doctor before use if the child is
  • When using this product
  • Stop use and ask a doctor if
• Directions
• Other Information
• Inactive Ingredients
• PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Assured Night 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 cold

Warnings

Do not use

• in a child under 4 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 doctor 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 occur
• 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

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

• may be given every 4 hours. Do not give more than 6 doses in 24 hours unless directed by a doctor

Other Information

• each TSP contains: sodium 9 mg
• store at 20°-25°C (68°-77°F)
• TAMPER EVIDENT: Do no use if foil seal over mouth of the bottle is torn, broken or missing.

Inactive Ingredients

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

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

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

NDC 59741-202-06

ASSURED ®

Night Time
Cold & Cough^*

Antihistamine/Cough Suppressant:
Diphenhydramine HCl

Nasal Decongestant:
Phenylephrine HCl

Relief for:

• Itchy Throat • Runny Nose
• Stuffy Nose • Cough

Grape
Flavor

4 FL OZ (118 mL)