DRYMAX AF- chlophedianol hydrochloride, chlorphenirmine maleate, pseudoephedrine hydrochloride syrup
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 Syrup

Drug Facts

Active ingredients
(in each 5 mL teaspoonful)
Chlophedianol HCl 25 mg
Chlorpheniramine Maleate 4 mg
Pseudoephedrine HCl 45 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, 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 information

Store at 59°-86°F (15°-30°C)

Inactive ingredients

Bitter 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 Packaging

The 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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64661-091
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Chlophedianol Hydrochloride (UNII: 69QQ58998Y) (Chlophedianol - UNII:42C50P12AP)	Chlophedianol Hydrochloride	25 mg in 5 mL
Chlorpheniramine Maleate (UNII: V1Q0O9OJ9Z) (Chlorpheniramine - UNII:3U6IO1965U)	Chlorpheniramine Maleate	4 mg in 5 mL
Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F)	Pseudoephedrine Hydrochloride	45 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Glycerin (UNII: PDC6A3C0OX)
Propylene Glycol (UNII: 6DC9Q167V3)
Water (UNII: 059QF0KO0R)
Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR)
Saccharin Sodium (UNII: SB8ZUX40TY)
Sorbitol (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64661-091-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2011	02/01/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	09/23/2011	02/01/2015

Labeler - JayMac Pharmaceuticals (830767260)

Revised: 9/2016

Document Id: 7bf73456-9980-4e9b-8c81-0d80c503334f

Set id: 44862a4c-e47c-48c7-af21-97a2e4344973

Version: 2

Effective Time: 20160922

JayMac Pharmaceuticals