Assured Night time Cold and Cough description, usages, side effects, indications, overdosage, supplying and lots more!

Assured Night time Cold and Cough

Bio-Pharm, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
ASSURED ® Night Time Cold & Cough

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active Ingredients (in each TSP (5 mL)) Purposes
Diphenhydramine HCL 6.25 mg Antihistamine/cough suppressant
Phenylephrine HCL 2.5 mg Nasal decongestant

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
Age Dose
Children under 4 years of age Do not use
Children 4 to under 6 years of age Do not use unless directed by doctor
Children 6 to under 12 years of age 2 TSP (10 mL)

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)

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

Assured Night time Cold and Cough

Diphenhydramine Hydrochloride and Phenylephrine Hydrochloride LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59741-202
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 6.25 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 2.5 mg

Inactive Ingredients

Ingredient Name Strength
saccharin sodium
CITRIC ACID MONOHYDRATE
FD&C RED NO. 40
BENZOIC ACID
water
EDETIC ACID
SODIUM CITRATE
sorbitol
propylene glycol
FD&C BLUE NO. 1
Vitis Vinifera Fruit Oil

Product Characteristics

Color
PURPLE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59741-202-06 118 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2011-11-01


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Be sure to consult your doctor before taking any medication!
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