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  5. Label Information: Supress A

FDA Label for Supress A

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH 1 ML)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. OTC - STOP USE
    7. OTC - PREGNANCY OR BREAST FEEDING
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. OTHER
    13. PRINCIPAL DISPLAY PANEL

Supress A Product Label

The following document was submitted to the FDA by the labeler of this product Kramer Novis. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients (In Each 1 Ml)



Dexbrompheniramine Maleate, 1 mg

Dextromethorphan HBr, 10 mg

Phenylephiren HCl, 5 mg


Purpose



Antihistamine

Cough suppressant

Expectorant


Uses



  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • sneezing
  • itchy nose or throat
  • runny nose
  • itchy, watery eyes
  • nasal congestion
  • temporarily controls cough due to minor throat and bronchial irritation associated with inhaled irritants
  • temporarily restores freer breathing through nose

Warnings



Do not use 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 taking this product.


Ask A Doctor Before Use If You Have



  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis, or emphysema
  • Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers
    • When using this product
    • do not exceed recommended dosage
    • excitability may occur, especially in children
    • may cause marked drowsiness
    • sedative and tranquilizers may increase drowsiness effect

Otc - Stop Use



Stop use and ask a doctor if

  • nervousness dizziness, or sleeplessness occur
  • new symptoms occur
  • symptoms do not improve within 7 days or are accompanied by fever
  • cough lasts more than 7 days, comes back or is accompanied by fever, rash, or persistent headache

    • These could be signs of a serious condition.


Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Keep Out Of Reach Of Children.



In case of accidental overdose, get medical help or contact a Poison Control Center right away.


Directions



Children 6 to under 12 years of age

  • 1 mL every 4 hours as needed, do not exceed 6 doses in any 24-hour, or as directed by a doctor
  • Children under 6, consult a doctor.
  • measure with the dosage device provided. Do not use any other device

Other Information



  • Tamper evident feature: Do not use if inner seal is torn, broken or missing.
  • Store at controlled room temperature 15°-30°C (59° to 86°F).
  • Avoid excessive heat and humidity.

Inactive Ingredients



Citric acid, flavor, glycerin, methylparaben, polysorbate, propylene glycol, propyl paraben, purified water, sodium citrate and sucralose.


Other



Made in the USA for Kramer Novis.

San Juan, PR 00917

(787) 767-2072 / www.kramernovis.com


Principal Display Panel





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