J-TAN  PD- brompheniramine maleate liquid 
JayMac Pharmaceuticals LLC

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 PD Drops

Drug Facts

Acitive ingredients
(in each 1 mL dropperful)
Brompheniramine Maleate, 1 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, water eyes

Warnings

Do not exceed recommended dosage.

Ask a doctor or pharmacist before use if the child has

  • a breathing problem such as chronic bronchitis
  • glaucoma

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

  • 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 (2.0 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 information

Store at 59°-86°F (15°-30°C)

Inactive ingredients

Banana Flavor, Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Strawberry Flavor.

Questions? Comments?

Call 1-866-280-5961

Product Packaging

The packaging below represents the labeling currently used.

Principal display panel and side panel for 30 mL label:

NDC 64661-031-30

J-TAN PD
Drops

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

ANTIHISTAMINE

SUGAR FREE∙ALCOHOL FREE
DYE FREE

STRAWBERRY-BANANA 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 PD Drops Packaging

J-TAN PD Drops Packaging

J-TAN PD Drops Packaging


J-TAN   PD
brompheniramine maleate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64661-031
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Brompheniramine Maleate (UNII: IXA7C9ZN03) (Brompheniramine - UNII:H57G17P2FN) Brompheniramine Maleate1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorSTRAWBERRY, BANANAImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64661-031-301 in 1 CARTON05/29/200708/01/2016
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/29/200708/01/2016
Labeler - JayMac Pharmaceuticals LLC (830767260)
Registrant - Great Southern Laboratories (056139553)

Revised: 10/2016
Document Id: 88b93030-b388-4403-9e25-f90a3dcef179
Set id: 4a03c41d-4a89-4e74-b287-ce166058458a
Version: 4
Effective Time: 20161005
 
JayMac Pharmaceuticals LLC