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


Neo AC Syrup

NEO AC - codeine phosphate, pseudoephedrine hydrochloride and pyrilamine 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 AC Syrup

Drug Facts

Active ingredients                                            
(in each 5 mL teaspoonful)
                                                                                      
Codeine Phosphate  10 mg
Pseudoephedrine Hydrochloride  30 mg
Pyrilamine Maleate  15 mg

Purpose

Antitussive
Cough Suppressant
Nasal Decongestant
Antihistamine

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
  • reduces swelling of nasal passages
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes

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 cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • chronic pulmonary disease, shortness of breath
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
Children who are taking other drugs should not take this product unless directed by a doctor.

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

  • may cause marked drowsiness
  • 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.
  • may cause or aggravate constipation
  • 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, get medical help or contact a Poison Control Center right away.

Directions

Do not exceed recommended dosage.
Adults and children 12 years of age and over:             
1-2 teaspoonfuls (5-10 mL) every 4 to 6 hours, not to exceed 8 teaspoonfuls in a 24 hour period
Children 6 to under 12 years of age:
1/2-1 teaspoonful (2.5-5 mL) every 4 to 6 hours, not to exceed 4 teaspoonfuls in a 24 hour period
Children under 6 years of age:
Consult a doctor

Other information

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

Inactive ingredients

Citric Acid, Glycerin, Orange Vanilla Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

Questions? Comments?

Call 864-286-8229

PRODUCT PACKAGING

The packaging below represents the labeling currently used:

Principal Display Panel and Side Panel for 473 mL Label:

NDC:16477-628-16

Neo AC
Syrup


Cough Suppressant
Nasal Decongestant
Antihistamine

Each 5 mL (1 teaspoonful) contains:
Codeine Phosphate ...................... 10 mg
(WARNING: MAY BE HABIT-FORMING.)
Pseudoephedrine HCl.................... 30 mg
Pyrilamine Maleate....................... 15 mg

Sugar Free / Alcohol Free / Dye Free

Orange - Vanilla Flavor

CV

LASER

16 fl oz (473 mL)


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.

THIS BOTTLE IS NOT TO BE DISPENSED TO CONSUMER.

LASER

Manufactured for:                               Manufactured by:
Laser Pharmaceuticals, LLC         Great Southern Laboratories
Greenville, SC 29615                          Houston, Texas 77099

Rev. 04/11

Neo AC Packaging

Neo AC Packaging



NEO  AC
codeine phosphate, pseudoephedrine hydrochloride, pyrilamine maleate syrup
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:16477-628
Route of Administration ORAL DEA Schedule CV    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Codeine Phosphate (Codeine) Codeine Phosphate 10 mg  in 5 mL
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride 30 mg  in 5 mL
Pyrilamine Maleate (Pyrilamine) Pyrilamine Maleate 15 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
Citric Acid  
Glycerin  
Propylene Glycol  
Water  
Sodium Citrate  
Saccharin Sodium  
Sorbitol  
Product Characteristics
Color      Score     
Shape Size
Flavor ORANGE (ORANGE-VANILLA) Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16477-628-16 473 mL in 1 BOTTLE None
2 NDC:16477-628-15 15 mL in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 09/22/2009

Labeler - Laser Pharmaceuticals LLC (614417132)

Revised: 06/2011 Laser Pharmaceuticals LLC



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


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