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Assured Night time Cold and Cough

Medically reviewed on October 31, 2017

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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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


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


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.

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


NDC 59741-202-06


Night Time
Cold & Cough*

Antihistamine/Cough Suppressant:
Diphenhydramine HCl

Nasal Decongestant:
Phenylephrine HCl

Relief for:

• Itchy Throat • Runny Nose
• Stuffy Nose • Cough


4 FL OZ (118 mL)

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 
Sodium Citrate 
Propylene Glycol 
Vitis Vinifera Fruit Oil 
Product Characteristics
FlavorGRAPEImprint Code
#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)

Bio-Pharm, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.