J-MAX

Dosage form: syrup
Ingredients: Guaifenesin 200mg in 5mL, Phenylephrine Hydrochloride 5mg in 5mL
Labeler: JayMac Pharmaceuticals LLC
NDC Code: 64661-011

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.

J-MAX Syrup

Drug Facts Active ingredients
(in each 5 mL teaspoonful)

Guaifenesin 200 mg
Phenylephrine Hydrochloride 5 mg



PurposeExpectorant
Nasal Decongestant

Usestemporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • nasal congestion
  • reduces swelling of 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 cough that lasts or is chronic such as occurs with smoking,asthma, chronic bronchitis or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

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 could 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 recommended dosage
Adults and Children
12 years of age and
over:

10 mL (2 teaspoonfuls)
every 4 hours, not to
exceed 12 teaspoonfuls
in 24 hours.
Children 6 to under
12 years of age:


5 mL (1 teaspoonful)
every 4 hours, not to
exceed 6 teaspoonfuls in
24 hours.
Children 2 to under
6 years of age:


2.5 mL (1/2 teaspoonful)
every 4 hours, not to
exceed 3 teaspoonfuls in
24 hours.
Children under 2
years of age:
Consult a physician.


Other informationStore at 59°-86°F (15°-30°C)

Inactive ingredientsCitric Acid, FD&C Red #40, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Strawberry Cream Flavor.

Questions? Comments?Call 1-866-280-5961

Product PackagingThe packaging below represents the labeling currently used.

Principal display panel and side panel for 473 mL label:

NDC 64661-011-16

J-MAX
Syrup

Expectorant / Nasal Decongestant


Each 5 mL (1 teaspoonful) contains:
Guaifenesin..............................200 mg
Phenylephrine Hydrochloride..........5 mg

Sugar Free / Alcohol Free

SHAKE WELL

Strawberry Cream Flavor

16 fl oz (473 mL)


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

THIS BOTTLE NOT TO BE DISPENSED TO CONSUMER.

Dispense in a tight, light-resistant container with a child-resistant cap.

Manufactured by:  Great Southern Laboratories, Houston, TX  77099

Manufactured for:  JayMac Pharmaceuticals, Sunset, LA  70584

Rev. 08/11







J-MAX 
guaifenesin, and phenylephrine hydrochloride syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64661-011
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (Guaifenesin) Guaifenesin200 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid 
Glycerin 
Propylene Glycol 
Water 
Sodium Citrate 
Saccharin Sodium 
Sorbitol 
Product Characteristics
Color    Score    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:64661-011-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/14/2006
Labeler - JayMac Pharmaceuticals LLC (830767260)
Registrant - Great Southern Laboratories (056139553)
Establishment
NameAddressID/FEIOperations
Great Southern Laboratories056139553manufacture

Revised: 09/2011
 
JayMac Pharmaceuticals LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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