J-TAN D PD

Dosage form: liquid
Ingredients: Brompheniramine Maleate 1mg in 1mL, Pseudoephedrine Hydrochloride 7.5mg in 1mL
Labeler: JayMac Pharmaceuticals LLC
NDC Code: 64661-032

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-TAN D PD Drops

Drug Facts Active ingredients
(in each 1 mL dropperful)

Brompheniramine Maleate 1 mg
Pseudoephedrine Hydrochloride 7.5 mg

PurposeAntihistamine
Nasal Decongestant

Usestemporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
  • 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
  • in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if the child has
  • a breathing problem such as chronic bronchitis
  • glaucoma
  • heart disease
  • high blood pressure
  •  thyroid disease
  • diabetes

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers.

When using this product
  • excitability may occur, especially in children
  • may cause drowsiness
  • sedatives and tranquilizers may increase the drowsiness effect

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or are accompanied by fever
  • new symptoms occur

Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away.

Directions
AGEDOSE
Children 6 to
12 years of age:
2 dropperfuls (2.0 mL) every 4 to 6 hours, not to
exceed 12 dropperfuls (12.0 mL) in 24 hours
Children 2 to
under 6 years
of age:
1 dropperful (1.0 mL) every 4 to 6 hours, not to
exceed 6 dropperfuls (6.0 mL) in 24 hours

Children under
2 years of age:
Consult a physician

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

Inactive ingredientsCitric Acid, Cotton Candy Flavor, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

Questions? Comments?1-866-280-5961

Product PackagingThe packaging below represents the labeling currently used.

Principal display panel and side panel for 30 mL label:

NDC 64661-032-30

J-TAN D PD
Drops


Each dropperful (1 mL) contains:
Brompheniramine Maleate.............................1 mg
Pseudoephedrine HCl.................................7.5 mg

ANTIHISTAMINE
NASAL DECONGESTANT

SUGAR FREE • ALCOHOL FREE
DYE FREE

COTTON CANDY FLAVOR

1 fl oz (30 mL)


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

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

The labeling for this product includes professional labeling which
is not intended for use by the general public.

Manufactured for:
JayMac Pharmaceuticals
Sunset, LA  70584

Manufactured by:
Great Southern Laboratories
Houston, TX  77099

Rev. 08/11







J-TAN  D PD
brompheniramine maleate and pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64661-032
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Brompheniramine Maleate (Brompheniramine) Brompheniramine Maleate1 mg  in 1 mL
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride7.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid 
Glycerin 
Propylene Glycol 
Water 
Sodium Citrate 
Saccharin Sodium 
Sorbitol 
Product Characteristics
Color    Score    
ShapeSize
FlavorCOTTON CANDYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:64661-032-301 BOTTLE (BOTTLE) in 1 CARTON
130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/05/2007
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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