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Dosage form: liquid
Ingredients: Dexbrompheniramine Maleate 0.667mg in 5mL, Dextromethorphan Hydrobromide 10mg in 5mL, Pseudoephedrine Hydrochloride 20mg in 5mL
Labeler: R. A. McNeil Company
NDC Code: 12830-816

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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Drug Facts

Active ingredients
(in each 5 mL teaspoonful)

Dexbrompheniramine Maleate 0.667 mg
Dextromethorphan HBr 10 mg
Pseudeophedrine HCl 20 mg

Purpose

Antihistamine
Antitussive
Cough Suppressant
Nasal Decongestant

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • cough due to minor throat and bronchial irritation
  • nasal congestion
  • reduces swelling of nasal passages

Warnings

Do not exceed recommended dosage.

Do not use this product
  • 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 you have
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product
  • excitability may occur, especially in children
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizes may increase the drowsiness effect
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache.  A persistent cough may be a sign of a serious condition.
  • nervousness, dizziness, or sleeplessness occur
  • new symptoms occur

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 exceed 4 doses in a 24 hour period.
Adults and children
12 years of age
and over:

3 teaspoonfuls (15 mL)
every 6 hours, not to
exceed 12 teaspoonfuls
in 24 hours
Children 6 to under
12 years of age:



1 1/2 teaspoonfuls
(7.5 mL) every 6 hours,
not to exceed 6
teaspoonfuls in
24 hours
Children under 6
years of age:
Consult a Physician.

Other information

Store at 59°-86°F (15°-30°C)

Inactive ingredients

Bitter Mask, Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Sucralose, Tutti Frutti Flavor.

Questions? Comments?

Call 1-423-493-9170

Product Packaging

The packaging below represents the labeling currently used.

Principal display panel and side panel for 473 mL label:

NDC 12830-0816-16

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Antihistamine • Antitussive
• Nasal Decongestant

Alcohol Free • Gluten Free
Sugar Free • Dye Free

EACH 5 mL (1 TEASPOONFUL) CONTAINS:
Dexbrompheniramine Maleate.............0.667 mg
Dextromethorphan HBr...........................10 mg
Pseudoephedrine HCl.............................20 mg

Tutti-Frutti Flavor

ONE PINT (473 mL)

Mfg. for R.A. McNeil Company
Chattanooga, TN  37406-3738

Rev. 09/11

Tamper evident by foil seal under cap. Do not
use if foil seal is broken or missing.

THIS BOTTLE IS NOT TO BE DISPENSED TO
THE CONSUMER.


Dispense in a tight, light-resistant container
with a child resistant cap.

Manufactured for:
R.A. McNeil Company
1150 Latta Street
Chattanooga, TN  37406-3738

Rev. 09/11





  

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dexbrompheniramine maleate, dextromethorphan hydrobromide, pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12830-816
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dexbrompheniramine Maleate (Dexbrompheniramine) Dexbrompheniramine Maleate0.667 mg  in 5 mL
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide10 mg  in 5 mL
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride20 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
Glycerin 
Propylene Glycol 
Water 
Sodium Citrate 
Saccharin Sodium 
Sorbitol 
Sucralose 
Product Characteristics
Color    Score    
ShapeSize
FlavorTUTTI FRUTTIImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:12830-816-16473 mL in 1 BOTTLE
2NDC:12830-816-3030 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/13/2011
Labeler - R. A. McNeil Company (008305220)

Revised: 01/2014
 
R. A. McNeil Company

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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