Medication Guide App

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Dosage form: liquid
Ingredients: Chlorpheniramine Maleate 2mg in 5mL, Dextromethorphan Hydrobromide 15mg in 5mL, Pseudoephedrine Hydrochloride 15mg in 5mL
Labeler: R.A. McNeil Company
NDC Code: 12830-810

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                                Purpose
(in each 5 mL teaspoonful)
Chlorpheniramine Maleate 2 mg................... Antihistamine
Dextromethorphan Hydrobromide 15 mg........... Antitussive
Pseudoephedrine Hydrochloride 15 mg......... Decongestant

Usestemporarily 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 mellitus

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

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

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

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

Keep out of the reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Directions Do not exceed recommended dosage.

Adults and children 12   
years of age and over:  
2 teaspoonfuls every 6 hours, not to
exceed 8 teaspoonfuls in a 24 hour period  
Children 6 to under
12 years of age:
1 teaspoonful every 6 hours, not to
exceed 4 teaspoonfuls in a 24 hour period
Children under 6 years
of age:
Not recommended for use

Other informationStore at 59o-86oF (15o-30oC)

Inactive ingredientsFD and C Yellow #6, glycerin, orange flavor, propylene glycol, purified water, sucrose.

Questions? Comments?Call 1-423-493-9170 Serious side effects associated with this product may be reported at this number.
M-F: 8:00 a.m. - 5:00 p.m. CST

PRODUCT PACKAGING:The packaging below represents the labeling currently used:

Principal Display Panel and Side Panel for 30 mL Label:

NDC 12830-0810-30

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Antihistamine / Antitussive
Decongestant

Sugar Free / Alcohol Free

EACH 5 mL (1 TEASPOONFUL) CONTAINS:

Chlorpheniramine Maleate.................. 2 mg
Dextromethorphan Hydrobromide...... 15 mg
Pseudoephedrine Hydrochloride........ 15 mg

Orange Flavor

1 fl. oz. (30 mL)

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

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

See package insert for full prescribing information.

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

Rev. 10/09




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chlorpheniramine maleate, dextromethorphan hydrobromiede, and pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12830-810
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chlorpheniramine Maleate (Chlorpheniramine) Chlorpheniramine Maleate2 mg  in 5 mL
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide15 mg  in 5 mL
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride15 mg  in 5 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:12830-810-3030 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/13/2008
Labeler - R.A. McNeil Company (008305220)

Revised: 02/2010
 
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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