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Name:Neo Dm Dropsdm
Manufacturer:Laser Pharmaceuticals, Llc
Category:Over-the-counter (OTC) Marketed Drugs


Neo DM DROPS

NEO DM DROPS DM - dextromethorphan hydrobromide, chlorpheniramine maleate and phenylephrine hydrochloride liquid 
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 DROPS

Active ingredients

(in each 1 mL dropperful)
Dextromethorphan Hbr 2.75 mg
Chlorpheniramine Maleate 0.75 mg
Phenylephrine HCl 1.75 mg

Purpose

Antitussive (cough suppressant)
Antihistamine
Nasal Decongestant

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
  • sneezing
  • itchy, water eyes
  • itching of the nose and throat

Warnings

Do not exceed recommended dosage.

Do not use this product

  • if you or your child are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI drug.  If you do not know if your child's or your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product or giving it to your child.

Ask a doctor before use if you or your child has

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes mellitus
  • glaucoma
  • a breathing problem such as chronic bronchitis
  • a cough that lasts or is chronic such as occurs with asthma
  • a cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you or your child are

taking sedatives or tranquilizers.

When using this product

  • you may get drowsy
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • excitability may occur, especially in children

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occurs
  • if symptoms do no get better within 7 days or are accompanied by a fever
  • 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.

Keep out of the reach of children.

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

Directions

  • Do not exceed recommended dosage.
  • Use enclosed dropper only.  Do not use any other dosage device.

Children 6 to under 12
years of age:
2 dropperfuls (2 mL) every 4 to 6 hours,
not to exceed 6 doses in 24 hours.
Children under 6
years of age:
Consult a doctor


Other information

Store at controlled room temperature 59° -86°F (15° -30°C)
[see USP Controlled Room Temperature].

Inactive ingredients

Glycerin, Propylene Glycol, Sorbitol, Citric Acid, Sodium Citrate, Sodium Saccharin, FD and C Red #40, Black Cherry Flavor, Purified Water

Questions? Comments?

Call your doctor for medical advice about side effects.  Serious side effects associated with use of this product may be reported to this number.  1-864-286-8229 (Mon-Fri) 8am-5pm EST.

PRODUCT PACKAGING:

The packaging below represents the labeling currently used:

Principal Display Panel and Side Panel for 30 mL Label:

NDC: 16477-620-30

Neo DM
DROPS

Antitussive
Antihistamine
Nasal Decongestant


Sugar Free / Alcohol Free

Black Cherry Flavored

Each dropperful (1.0 mL) for oral administration contains:
Dextromethorphan HBr...................................2.75 mg
Chlorpheniramine Maleate..............................0.75 mg
Phenylephrine HCl.........................................1.75 mg

1 fl oz (30 mL)

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

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

Manufactured for:
Laser Pharmaceuticals, LLC
Greenville, SC  29615                                 Rev. 06/10


Neo DM DROPS Packaging



Neo DM DROPS Packaging


Neo DM DROPS Packaging




NEO DM DROPS  DM
dextromethophan hydrobromide, chlorpheniramine maleate, phenylephrine hydrochloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:16477-620
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 2.75 mg  in 1.0 mL
Chlorpheniramine Maleate (Chlorpheniramine) Chlorpheniramine Maleate 0.75 mg  in 1.0 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 1.75 mg  in 1.0 mL
Inactive Ingredients
Ingredient Name Strength
Glycerin  
Propylene Glycol  
Sorbitol  
Citric Acid  
Saccharin Sodium  
Water  
Product Characteristics
Color      Score     
Shape Size
Flavor CHERRY Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16477-620-30 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
1 30 mL in 1 BOTTLE This package is contained within the CARTON (16477-620-30)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 10/06/2006

Labeler - Laser Pharmaceuticals, LLC (614417132)

Revised: 12/2010 Laser Pharmaceuticals, LLC



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


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