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Neo

Laser Pharmaceuticals LLC

Neo AC Syrup


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

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

Purpose





Neo 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

Ask a doctor or pharmacist before use if you are


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


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

Neo 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?


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

Neo

Neo

Codeine Phosphate, Pseudoephedrine Hydrochloride, Pyrilamine Maleate SYRUP

Product Information

Product Type Human otc drug label Item Code (Source) NDC:16477-628
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CODEINE PHOSPHATE CODEINE ANHYDROUS 10 mg
Pseudoephedrine Hydrochloride Pseudoephedrine 30 mg
PYRILAMINE MALEATE PYRILAMINE 15 mg

Inactive Ingredients

Ingredient Name Strength
Citric acid
GLYCERIN
propylene glycol
water
SODIUM CITRATE
saccharin sodium
sorbitol

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:16477-628-16 473 in 1 BOTTLE
2 NDC:16477-628-15 15 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2009-09-22


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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