Runny Nose and Cough

Dosage form: liquid
Ingredients: Brompheniramine Maleate 0.5mg in 5mL, Dextromethorphan Hydrobromide 5mg in 5mL, Phenylephrine Hydrochloride 1.25mg in 5mL
Labeler: Accudial Pharmaceutical, Inc.
NDC Code: 45014-153

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.

Children's
ACCUDIAL

RUNNY NOSE & COUGH

Drug Facts

Active ingredients
(in each 5 mL tsp)
Purposes
Brompheniramine maleate, USP .5 mgAntihistamine
Dextromethorphan HBr, USP 5 mgCough suppressant
Phenylephrine HCl, USP 1.25 mgNasal decongestant

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever, or other upper respiratory allergies
  • temporarily relieves these symptoms due to hay fever (allergic rhinitis):
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
  • temporarily restores freer breathing through the nose

Warnings

Do not use
  • to sedate a child or to make a child sleepy
  • if you are now 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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if the child has
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

When using this product
  • do not use more than directed
  • may cause marked drowsiness
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Stop use and ask a doctor if
  • you get nervous, dizzy, or sleepless
  • symptoms do not get better within 7 days or are accompanied by fever
  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

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

Directions
  • do not take more than 4 doses in any 24-hour period
  • to find right dose, use rotating bottle label to dose by weight; otherwise, use chart below to dose by age
  • specifically designed for use with enclosed dosing spoon. Use only enclosed dosing spoon to dose this product. Do not use any other dosing device
agedose
children 6 to under 12 years1½-3 tsp. (7.5-15 mL) every 6 hours
children under 6 yearsdo not use

Other information
  • each teaspoon contains: sodium 3 mg
  • store at 20°-25°C (68°-77°F)

Inactive ingredients

artificial flavor, citric acid, FD&C blue no. 1, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol.

Questions?

877-434-2036

PRINCIPAL DISPLAY PANEL - 118 mL Carton

CHILDREN'S
ACCUDIAL

ROTATING DOSING LABEL

ACCURATE DOSING
BY WEIGHT

Nasal Decongestant
Antihistamine
Cough Suppressant

RELIEVES
Nasal Congestion
Runny Nose
Itchy, Watery Eyes
Coughing, Sneezing

For Ages 6 to under 12

Alcohol Free
Compares to the
active ingredients in
Children's Dimetapp®
Cold & Cough.

GRAPE
FLAVOR

4 FL. OZ.
(118 mL)
NDC 45014-153-04

Runny Nose & Cough

RUNNY NOSE AND COUGH 
brompheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45014-153
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Brompheniramine Maleate (Brompheniramine) Brompheniramine Maleate0.5 mg  in 5 mL
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide5 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride1.25 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Grape 
Citric Acid Monohydrate 
FD&C Blue No. 1 
FD&C Red No. 40 
Glycerin 
Propylene Glycol 
Water 
Sodium Benzoate 
Sodium Citrate 
Saccharin Sodium  
Sorbitol 
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:45014-153-04118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34111/04/2009
Labeler - Accudial Pharmaceutical, Inc. (831999201)

Revised: 11/2009
 
Accudial Pharmaceutical, 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.

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