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Name:Neodm
Manufacturer:Laser Pharmaceuticals Llc
Category:Over-the-counter (OTC) Marketed Drugs


NEO DM SYRUP

NEO DM - dextromethorphan hydrobromide, pseudoephedrine hydrochloride and brompheniramine maleate syrup 
Laser Pharmaceuticals LLC

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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NEO DM SYRUP

Drug Facts

Active ingredients                                   Purpose
(in each 5 mL teaspoonful)
Dextromethorphan Hydrobromide 30 mg................... Antitussive
Pseudoephedrine Hydrochloride 50 mg.........Nasal Decongestant
Brompheniramine Maleate 3 mg........................... Antihistmaine

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
  • cough due to minor throat and bronchial irritation
  • nasal congestion
  • swelling of nasal passages
  • runny nose
  • itchy, watery eyes
  • sneezing

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

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes mellitus
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • 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)

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

  • you may get drowsy
  • avoid alcoholic drinks
  • 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

  • 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.

Directions

Do not exceed 4 doses in a 24 hour period.

Adults and children
12 years of age
and over:                
1 teaspoonful every 6 hours.
Children 6 to under
 12 years of age:
1/2 teaspoonful every 6 hours.
Children under
6 years of age:
Consult a physician.

Other information

Store at 59o-86oF (15o-30oC)

Inactive ingredients

Berry Vanilla Flavor, Citric Acid, FD and C Blue #1, FD and 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:

NDC: 16477-562-01

NEO DM SYRUP

Antitussive
Nasal Decongestant
Antihistamine

Sugar Free / Alcohol Free


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

LASER

16 fl oz (473 mL)


Side Panel:

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

Manufactured by:
Great Southern Laboratories
Houston, TX 77099

Rev. 10/09

Neo DM Packaging

Neo DM Packaging


NEO  DM
dextromethorphan hydrobromide, pseudoephedrine hydrochloride, and brompheniramine maleate syrup
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:16477-562
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 30 mg  in 5 mL
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride 50 mg  in 5 mL
Brompheniramine Maleate (Brompheniramine) Brompheniramine Maleate 3 mg  in 5 mL
Product Characteristics
Color      Score     
Shape Size
Flavor BERRY Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16477-562-01 473 mL in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 01/02/2008

Labeler - Laser Pharmaceuticals LLC (614417132)
Registrant - Great Southern Laboratories (056139553)
Establishment
Name Address ID/FEI Operations
Great Southern Laboratories 056139553 manufacture

Revised: 12/2009 Laser Pharmaceuticals LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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