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Assured Night time Cold and Cough

Dosage form: liquid
Ingredients: Diphenhydramine Hydrochloride 6.25mg in 5mL, Phenylephrine Hydrochloride 2.5mg in 5mL
Labeler: Bio-Pharm, Inc.
NDC code: 59741-202

ASSURED ®
Night Time
Cold & Cough

Drug Facts

Active Ingredients (in each TSP (5 mL))Purposes
Diphenhydramine HCL 6.25 mgAntihistamine/cough suppressant
Phenylephrine HCL 2.5 mgNasal 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
AgeDose
Children under 4 years of ageDo not use
Children 4 to under 6 years of ageDo not use unless directed by doctor
Children 6 to under 12 years of age2 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)

ASSURED NIGHT TIME COLD AND COUGH 
diphenhydramine hydrochloride and phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59741-202
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine Hydrochloride6.25 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:59741-202-06118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34111/01/2011
Labeler - Bio-Pharm, Inc. (801652546)

Revised: 10/2011
 
Bio-Pharm, Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.