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

(in each 5 mL teaspoonful)

Brompheniramine Maleate

3 mg

Dextromethorphan Hydrobromide

30 mg

Pseudoephedrine Hydrochloride

50 mg

Purpose

Antihistamine

Antitussive

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 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 are

taking 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 information

Store at 59° -86 °F (15 °-30 °C)

Inactive ingredients

Berry 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 Syrup Packaging
NEO DM Syrup Packaging

NEO  DM
dextromethorphan hydrobromide, pseudoephedrine hydrochloride, and brompheniramine maleate syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16477-562
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE50 mg  in 5 mL
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE3 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16477-562-01473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/02/200807/03/2017
2NDC:16477-562-3030 mL in 1 BOTTLE; Type 0: Not a Combination Product01/21/200807/03/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/02/200807/03/2017
Labeler - Laser Pharmaceuticals LLC (614417132)

Revised: 12/2017
 
Laser Pharmaceuticals LLC