Medication Guide App

Tekral

Dosage form: tablet, multilayer
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 50mg, PSEUDOEPHEDRINE HYDROCHLORIDE 60mg
Labeler: Capellon Pharmaceuticals, LLC
NDC Code: 64543-026

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.

TEKRAL® Tablets

Drug Facts

Active Ingredients (per tablet)

Diphenhydramine Hydrochloride  50 mg

Pseudoephedrine Hydrochloride  60 mg

Purpose

Diphenhydramine Hydrochloride       Antihistamine / Antitussive

Pseudoephedrine Hydrochloride       Nasal Decongestant

Uses

For the temporary relief of

  • cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes due to hay fever or other upper respiratory allergies
  • nasal congestion

Temporarily helps

  • clear nasal passages
  • shrink swollen membranes

Warnings
  • Do not exceed recommended dosage
  • May cause excitability especially in children
  • May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect.

When using this product
  • Avoid alcoholic beverages
  • Use caution when driving a motor vehicle or operating machinery.

Do not use
  • with any other product containing diphenhydramine, even one used on skin
  • If you have a breathing problem such as emphysema or chronic bronchitis
  • 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

Stop use and ask a doctor
  • If nervousness, dizziness, or sleeplessness occur.
  • A persistent cough may be a sign of a serious condition. If cough or other symptoms do not improve within 7 days, tend to recur, or are accompanied by fever, rash, or persistent headache, consult a doctor.

Ask a doctor before use if you have
  • glaucoma
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland
  • a persistent or chronic cough or breathing problem such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus)

Ask a doctor or pharmacist
  • before taking this product if you are taking sedatives or tranquilizers

If pregnant or breast feeding

Ask a health professional before use.

Keep out of reach of children

In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Directions
  • Adults (12 and older): One tablet every 4 to 6 hours. Not to exceed 4 doses in 24 hours.
  • Children under 12 years of age: Consult a physician.[/S]

Other information

store at 20°-25°C (68°-77°F)

Inactive ingredients

colloidal silicon dioxide, crospovidone polyplasdone, D&C Yellow #10, Green LKB #LB-620, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone

Questions or Comments?

Serious side effects may be reported to this number, call (817) 595-5820. (8 am to 5 pm CST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Figure 1: 90 count bottle label

TEKRAL 
diphenhydramine hcl and pseudoephedrine hcl tablet, multilayer
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64543-026
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSPOVIDONE 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE K30 
Product Characteristics
ColorYELLOW (light) , GREEN (light) Scoreno score
ShapeOVALSize19mm
FlavorImprint CodeT026
Contains    
Packaging
#Item CodePackage Description
1NDC:64543-026-9090 TABLET, MULTILAYER (TABLET) in 1 BOTTLE
2NDC:64543-026-0212 POUCH (POUCH) in 1 CARTON
21 TABLET, MULTILAYER (TABLET) in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/01/201108/31/2013
Labeler - Capellon Pharmaceuticals, LLC (124568093)
Registrant - Capellon Pharmaceuticals, LLC (124568093)
Establishment
NameAddressID/FEIOperations
Sovereign Pharmaceuticals, LLC623168267MANUFACTURE(64543-026)

Revised: 01/2013
 
Capellon 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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