Neo DM

Dosage form: syrup
Ingredients: Dextromethorphan Hydrobromide 30mg in 5mL, Pseudoephedrine Hydrochloride 50mg in 5mL, Brompheniramine Maleate 3mg in 5mL
Labeler: Laser Pharmaceuticals LLC
NDC Code: 16477-562

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.

NEO DM SYRUP

Drug Facts Active ingredients                                  
(in each 5 mL teaspoonful)
Brompheniramine Maleate
3 mg
Dextromethorphan Hydrobromide
30 mg
Pseudoephedrine Hydrochloride
50 mg

PurposeAntihistamine
Antitussive
Nasal 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 the 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 aretaking sedatives or tranquilizers.

When using this product
  • excitability may occur, especially in children
  • may cause marked drowsiness
  • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
  • avoid alcoholic drinks
  • 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.  A persistent cough may be a sign of a serious condition.
  • 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:       
        
1 teaspoonful (5 mL)
every 6 hours, not to
exceed 4 teaspoonfuls
in 24 hours.

Children 6
to under 12
years of age:
1/2 teaspoonful (2.5 mL)
every 6 hours, not to exceed
2 teaspoonfuls in 24 hours.
Children
under 6
years of age:
Consult a physician.

Other informationStore at 59°-86°F (15°-30°C)

Inactive ingredientsBerry Vanilla Flavor, Citric Acid, FD&C Blue #1, FD&C Red #40, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

Questions? Comments?Call 1-864-286-8229

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

Principal display panel and side panel for 30 mL label:

NDC:
16477-562-30

NEO DM
Syrup

Antihistamine
Antitussive
Nasal Decongestant

Sugar Free / Alcohol Free


Each 5 mL (1 teaspoonful) contains:
Brompheniramine Maleate............3 mg
Dextromethorphan HBr...............30 mg
Pseudoephedrine HCl.................50 mg

Professional Sample:
Not For Sale


30 mL (1 fl oz)

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

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

LASER

Manufactured for:
Laser Pharmaceuticals, LLC
Greenville, SC 29615

Rev. 09/11











NEO  DM
dextromethorphan hydrobromide, pseudoephedrine hydrochloride, and brompheniramine maleate syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16477-562
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide30 mg  in 5 mL
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride50 mg  in 5 mL
Brompheniramine Maleate (Brompheniramine) Brompheniramine Maleate3 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid 
Glycerin 
Propylene Glycol 
Water 
Sodium Citrate 
Saccharin Sodium 
Sorbitol 
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:16477-562-01473 mL in 1 BOTTLE
2NDC:16477-562-3030 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/02/2008
Labeler - Laser Pharmaceuticals LLC (614417132)
Registrant - Great Southern Laboratories (056139553)
Establishment
NameAddressID/FEIOperations
Great Southern Laboratories056139553manufacture

Revised: 10/2011
 
Laser Pharmaceuticals LLC

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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