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Daytime Cough and Cold by Accudial Pharmaceutical, Inc.

Medically reviewed on February 6, 2018

Dosage form: solution
Ingredients: Dextromethorphan Hydrobromide 5mg in 5mL, Phenylephrine Hydrochloride 2.5mg in 5mL
Labeler: Accudial Pharmaceutical, Inc.
NDC Code: 45014-158

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.

Daytime Cough & Cold

Drug Facts

Active ingredient (in each 5 mL = 1 teaspoon)Purpose
Dextromethorphan HBr, USP 5 mgCough suppressant
Phenylephrine HCl, USP 2.5 mgNasal decongestant

Uses

Temporarily relieves

  • nasal and sinus congestion
  • cough due to minor throat and bronchial irritation as may occur with a 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.

Consult your pharmacist or health care provider for any appropriate, additional dosage delivery device necessary for use when a physician recommends a dose that is different than the doses that appear on the dosage delivery device that accompanies this product.

Age (yr)Dose (TSP)
under 4 yrs.ask a doctor
4 to under 61 TSP
6 to under 122 TSP
or as directed by a doctor
TSP = teaspoon

Keep out of reach of children.

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Prompt medical attention is critical, even if you do not notice any signs or symptoms.

Other information
  • each teaspoon contains: sodium 2 mg
  • store between 20°-25°C (68°-77°F)
  • tamper evident: do not use if foil seal over the mouth of the bottle is torn, broken, or missing.

Directions
  • may be given every 4 hours
  • do not use more than 6 times in 24 hours
  • use only enclosed dosing cup to dose this product. Do not use any other dosing device.

Questions?

877-434-2036

Inactive ingredients

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

Distributed by: AccuDial® Pharmaceutical, Inc.
Palm Beach Gardens, FL 33408

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

ACCUDIAL®

Children's
Daytime
Cough and Cold

Dextromethorphan HBr (Cough Suppressant)

Phenylephrine HCl (Nasal Decongestant)

Relieves Cough • Stuffy Nose

Earth-Friendly
Package!

For Ages 4 yrs to under 12 yrs

Tamper Evident

Compares to Children's Triaminic ®
Day Time Cold & Cough

CHERRY
FLAVOR

NDC 45014-158-04
4 FL. OZ. (118 mL)

DAYTIME COUGH AND COLD 
dextromethorphan hydrobromide and phenylephrine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45014-158
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide5 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Benzoic Acid 
Citric Acid Monohydrate 
Edetate Disodium 
FD&C Red No. 40 
Propylene Glycol 
Water 
Sodium Citrate 
Saccharin Sodium 
Sorbitol 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:45014-158-04118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34102/01/2013
Labeler - Accudial Pharmaceutical, Inc. (831999201)
Establishment
NameAddressID/FEIOperations
Bio-Pharm, Inc.801652546ANALYSIS(45014-158), MANUFACTURE(45014-158), RELABEL(45014-158), REPACK(45014-158)

 
Accudial Pharmaceutical, Inc.

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Further information

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

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