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DryMax AF by JayMac Pharmaceuticals

Dosage form: syrup
Ingredients: Chlophedianol Hydrochloride 25mg in 5mL, Chlorpheniramine Maleate 4mg in 5mL, Pseudoephedrine Hydrochloride 45mg in 5mL
Labeler: JayMac Pharmaceuticals
NDC Code: 64661-091

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.

DryMax AF Syrup

Drug Facts Active ingredients
(in each 5 mL teaspoonful)

Chlophedianol HCl 25 mg
Chlorpheniramine Maleate 4 mg
Pseudoephedrine HCl 45 mg

PurposeCough Suppressant
Antihistamine
Nasal Decongestant

Usestemporarily 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
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, water eyes
  • 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 or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
Ask a doctor before use if you are taking sedatives or tranquilizers.

When using this product
  • excitability may occur, especially in children
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
  • use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if
  • 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.
  • nervousness, dizziness, or sleeplessness occur
  • new symptoms occur

If pregnant or breast-feeing, 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:
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 teaspoonfuls (2.5 mL) every
6 hours, not to exceed 2
teaspoonfuls in 24 hours
Children under 6
years of age
Consult a doctor


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

Inactive ingredientsBitter Mask, Citric Acid, FD&C Blue #1, FD&C Red #40, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol 

Questions? Comments?Serious side effects may be reported to this number, call
1-866-280-5961. (8 am to 5 pm)

Product PackagingThe packaging below represents the labeling currently used.

Principal display panel and side panel for 118 mL label:

NDC 64661-091-04

DryMax AF
Syrup

Patent Pending

Each teaspoonful (5 mL) for oral
administration contains:

Chlophedianol HCl............................25 mg
Chlorpheniramine Maleate...................4 mg
Pseudoephedrine HCl.......................45 mg

COUGH SUPPRESSANT • ANTIHISTAMINE
NASAL DECONGESTANT

ALCOHOL FREE

JayMac Pharmaceuticals
4 fl oz (118 mL)


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

Supplied 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

Patent Pending

Rev. 08/11






DRYMAX  AF
chlophedianol hydrochloride, chlorphenirmine maleate, pseudoephedrine hydrochloride syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64661-091
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chlophedianol Hydrochloride (Chlophedianol) Chlophedianol Hydrochloride25 mg  in 5 mL
Chlorpheniramine Maleate (Chlorpheniramine) Chlorpheniramine Maleate4 mg  in 5 mL
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride45 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid 
Glycerin 
Propylene Glycol 
Water 
Sodium Citrate 
Saccharin Sodium 
Sorbitol 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:64661-091-04118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/23/2011
Labeler - JayMac Pharmaceuticals (830767260)

Revised: 09/2011
 
JayMac Pharmaceuticals

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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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