Tekral Tablets

Name: Tekral Tablets

Tekral Tablets Dosage and Administration

Adults and children over 12 years of age: One tablet every 12 hours. Not to exceed 2 tablets in 24 hours.

Children 6 to 12 years of age: Consult Physician

Children under 6 years of age: Do not give this product to children under 6 years of age except under the advice and supervision of a physician.

How is Tekral Tablets Supplied

Tekral( tablets are supplied as light green and light yellow bilayered capsule shaped tablets with "TEKRAL" debossed on one side of the tablet, and scored on the opposite side. Available in bottles of 90 tablets (NDC 64543-025-90), and physician samples of 2 tablet blister packs, (NDC 64543-025-02).

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Storage and Handling

Dispense in tight, light-resistant containers as defined in the USP/NF with child-resistant closures.

Store at controlled room temperature 20°-25°C (68°- 77°F); see USP Controlled Room Temperature.

Call Your Doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Rx Only

Distributed by:

Capellon Pharmaceuticals, Ltd.

Fort Worth, TX 76118

500385

Iss. 09/09

Principal display panel

Figure 1: Bottle label

Figure 2: Sample Label

Figure 3: Blister Carton

TEKRAL 
diphenhydramine / pseudoephedrine hcl tablet, multilayer, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:64543-025
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 100 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE  
SILICON DIOXIDE  
D&C YELLOW NO. 10  
FD&C BLUE NO. 1  
LACTOSE MONOHYDRATE  
MAGNESIUM STEARATE  
HYPROMELLOSE 2208 (4000 MPA.S)  
CELLULOSE, MICROCRYSTALLINE  
POVIDONE K30  
STEARIC ACID  
Product Characteristics
Color YELLOW (Light) , GREEN (Light) Score 2 pieces
Shape CAPSULE Size 19mm
Flavor Imprint Code TEKRAL
Contains     
Packaging
# Item Code Package Description
1 NDC:64543-025-90 90 TABLET, MULTILAYER, EXTENDED RELEASE (TABLET) in 1 BOTTLE
2 NDC:64543-025-02 12 BLISTER PACK (BLISTER PACK) in 1 CARTON
2 2 TABLET, MULTILAYER, EXTENDED RELEASE (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 11/07/2009 11/30/2012
Labeler - Capellon Pharmaceuticals, LLC (124568093)
Registrant - Capellon Pharmaceuticals, LLC (124568093)
Establishment
Name Address ID/FEI Operations
Sovereign Pharmaceuticals, LLC 623168267 MANUFACTURE
Revised: 01/2010   Capellon Pharmaceuticals, LLC

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
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