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Daytime Cough And Cold by Accudial Pharmaceutical, Inc.

Dosage form: liquid
Ingredients: Dextromethorphan Hydrobromide 5mg in 5mL, Phenylephrine Hydrochloride 1.25mg in 5mL
Labeler: Accudial Pharmaceutical, Inc.
NDC Code: 45014-152

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.

Drug Facts

Active ingredients
(in each 5 mL, 1 teaspoonful)
Purposes
Dextromethorphan HBr, USP 5 mgCough suppressant
Phenylephrine HCl, USP 1.25 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.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions
  • May be given every 6 hours. Do not give more than 4 doses in 24 hours unless directed by a doctor.
Children under 4 years of agedo not use
Children 4 to under 6 years of age1-1½ tsp.
(5-7.5 mL)
Children 6 to under 12 years of age1½-3 tsp.
(7.5-15 mL)

Other information
  • each teaspoon contains: sodium 2 mg
  • store at controlled room temperature 20°-25°C (68°-77°F)

Inactive ingredients

Artificial Flavor, Benzoic Acid, Citric Acid, EDTA Disodium, FD&C Red #40, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

877-434-2036

Manufactured for
ACCUDIAL
PHARMACEUTICAL, INC.
AccurateDose.com
Palm Beach Gardens, FL 33410

Distributed by:
LeSaint Logistics
Corporate Headquarters
2570 Northwest Parkway
Elgin, IL 60124

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

CHILDREN'S
ACCUDIAL

ROTATING DOSING LABEL

Daytime
Cough & Cold

ACCURATE DOSING
BY WEIGHT

Dextromethorphan HBr
(Cough Suppressant)

Phenylephrine HCl
(Nasal Decongestant)

Cough
Stuffy Nose

For Ages 4 to under 12

Compares to the active
ingredients in Children's
Triaminic® Day Time
Cold & Cough.

CHERRY
FLAVOR

4 FL.OZ.
(118 mL)

NDC 45014-152-04

DAYTIME COUGH AND COLD 
dextromethorphan hydrobromide and phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45014-152
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 Hydrochloride1.25 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Cherry 
Benzoic acid 
Citric Acid Monohydrate 
Edetate Disodium 
FD&C red no. 40 
Propylene Glycol 
Water 
Sodium Citrate 
Saccharin Sodium 
Sorbitol 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:45014-152-04118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34110/26/2009
Labeler - Accudial Pharmaceutical, Inc. (831999201)

Revised: 09/2011
 
Accudial Pharmaceutical, Inc.

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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.

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