ASSURED DAY TIME COLD AND COUGH- dextromethorphan hydrobromide and phenylephrine hydrochloride liquid 
Bio-Pharm, Inc.

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.

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ASSURED ®
Day Time
Cold & Cough

Drug Facts

Active Ingredients (in each TSP (5 mL))Purposes
Dextromethorphan HBr 5 mgCough suppressant
Phenylephrine HCL 2.5 mgNasal decongestant

Uses

Temporarily relieves:

  • nasal & 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.

Ask a doctor before use if the child has

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • cough that occurs with too much phlegm (mucus)
  • chronic cough that lasts, or as occurs with asthma

When using this product

  • do not exceed recommended dosage

Stop use and ask a doctor if

  • nervousness, dizziness or sleeplessness occurs
  • 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 age1 TSP (5 mL)
Children 6 to under 12 years of age2 TSP (10 mL)

Other Information

  • each TSP contains: sodium 2 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 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 59741-201-06

ASSURED ®

Day Time
Cold & Cough*

Cough Suppressant:
Dextromethorphan HBr

Nasal Decongestant:
Phenylephrine HCl

Relief for:

• Cough• Stuffy Nose

Cherry
Flavor

4 FL OZ (118 mL)

Principal Display Panel - 118 mL Bottle Label
ASSURED DAY TIME COLD AND COUGH 
dextromethorphan hydrobromide and phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59741-201
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide5 mg  in 5 mL
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
saccharin sodium (UNII: SB8ZUX40TY)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
FD&C Red no. 40 (UNII: WZB9127XOA)  
benzoic acid (UNII: 8SKN0B0MIM)  
Water (UNII: 059QF0KO0R)  
Edetic Acid (UNII: 9G34HU7RV0)  
Sodium Citrate (UNII: 1Q73Q2JULR)  
Sorbitol (UNII: 506T60A25R)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Prunus Serotina Bark (UNII: 5D48E975HA)  
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59741-201-06118 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/201110/31/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34111/01/201110/31/2016
Labeler - Bio-Pharm, Inc. (801652546)
Establishment
NameAddressID/FEIBusiness Operations
Bio-Pharm, Inc.801652546manufacture(59741-201)

Revised: 8/2018
Document Id: 9fd49567-10e2-4d46-a2ec-0cd53a937f95
Set id: 0badeec0-552d-49bd-8681-7949b828be21
Version: 2
Effective Time: 20180824
 
Bio-Pharm, Inc.