DRYMAX AF- chlophedianol hydrochloride, chlorpheniramine maleate, phenylephrine hydrochloride tablet 
JayMac Pharmaceuticals

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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DryMax AF Tablets

Drug Facts

Active ingredients
(in each tablet)

Chlophedianol HCl 25 mg
Chlorpheniramine Maleate 4 mg
Phenylephrine HCl 15 mg

Purpose

Cough Suppressant
Antihistamine
Nasal Decongestant

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
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery 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 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
  • 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-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:
1 tablet every 6 hours,
not to exceed 4 tablets
in 24 hours.
Children 6 to under
12 years of age:

1/2 tablet every 6 hours,
not to exceed 2 tablets
in 24 hours.
Children under
6 years of age:
Consult a doctor.


Other information

Store at 59° - 86°F (15° - 30°C).
DryMax AF Tablets are blue to light blue, mottled, biconvex round shape tablets, debossed "D" bisect "M" on one side and plain on the other side.

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1 aluminum lake, magnesium stearate, and microcrystalline cellulose.

Questions? Comments?

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

Product Packaging

The packaging below represents the labeling currently used.

Principal display panel and side panel for 20 tablets label:

NDC 64661-092-20


DryMax AF
Tablets


Patent Pending

Each tablet contains:
Chlophedianol HCl............................25 mg
Chlorpheniramine Maleate...................4 mg
Phenylephrine HCl............................15 mg

COUGH SUPPRESSANT • ANTIHISTAMINE
NASAL DECONGESTANT


20 Tablets

JayMac Pharmaceuticals


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. 11/12


DryMax AF Tablets Packaging


DryMax AF Tablets Packaging



DRYMAX  AF
chlophedianol hydrochloride, chlorpheniramine maleate, phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64661-092
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chlophedianol Hydrochloride (UNII: 69QQ58998Y) (Chlophedianol - UNII:42C50P12AP) Chlophedianol Hydrochloride25 mg
Chlorpheniramine Maleate (UNII: V1Q0O9OJ9Z) (Chlorpheniramine - UNII:3U6IO1965U) Chlorpheniramine Maleate4 mg
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride15 mg
Inactive Ingredients
Ingredient NameStrength
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Croscarmellose Sodium (UNII: M28OL1HH48)  
Magnesium Stearate (UNII: 70097M6I30)  
Microcrystalline Cellulose (UNII: OP1R32D61U)  
Product Characteristics
Colorblue (light blue) Score2 pieces
ShapeROUNDSize9mm
FlavorImprint Code D;M
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64661-092-2020 in 1 BOTTLE; Type 0: Not a Combination Product02/19/201302/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/19/201302/01/2015
Labeler - JayMac Pharmaceuticals (830767260)
Registrant - Pernix Manufacturing, LLC (078641814)

Revised: 10/2016
 
JayMac Pharmaceuticals