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  5. Label Information: Rydex

FDA Label for Rydex

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. USES
    3. WARNINGS
    4. DO NOT USE THIS PRODUCT
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. IF PREGNANT OR BREAST-FEEDING,
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS? COMMENTS?
    15. PRODUCT PACKAGING:

Rydex Product Label

The following document was submitted to the FDA by the labeler of this product Centurion Labs. 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.

Drug Facts



Active ingredients                                                          Purpose(in each 5 mL teaspoonful)Brompheniramine Maleate 1.33 mg..................................................AntihistamineCodeine Phosphate*6.33 mg............................................................Antitussive                                                                                            (Cough Suppressant)*WARNING:  May be habit formingPseudoephedrine Hydrochloride 10 mg.............................................Nasal Decongestant

Uses



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

  • cough due to minor throat and bronchial irritation
  • nasal congestion
  • reduces swelling of the nasal passages
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, water eyes

Warnings



Do not exceed recommended dosage.

Do Not Use This Product



  • 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.

Ask A Doctor Before Use If You Have



  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • chronic pulmonary disease or shortness of breath, or children who are taking other drugs
  • heart disease
  • high blood pressure
  • thyroid disease
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland


Ask A Doctor Or Pharmacist Before Use If You Are



Taking sedatives or tranquilizers.

When Using This Product



  • excitability may occur, especially in children
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop Use And Ask A Doctor If



  • nervousness, dizziness, or sleeplessness occur
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache.  These could be signs of a serious condition.
  • may cause or aggravate constipation


If Pregnant Or Breast-Feeding,



Ask a health professional before use.

Keep Out Of Reach Of Children.



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

Directions



Do not exceed recommended dosage.


Adults and children 12 years of age
and over:
3 teaspoonfuls (15 mL) every 4 to 6 hours,
 not to exceed 18 teaspoonfuls in a 24 hour period.
Children 6 to under 12 years of age:
1 1/2 teaspoonfuls (7.5 mL) every 4 to 6 hours,
not to exceed 9 teaspoonfuls in a 24 hour period.
Not recommended for children under 6 years of age.



Other Information



Each 5 mL (one teaspoonful) contains:  sodium 2 mgStore at 59° - 86°F (15° - 30°C)

Inactive Ingredients



Citric Acid, Cotton Candy Flavor, FD and C Red #40, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, and Sorbitol.

Questions? Comments?



Call 1-866-959-4880Mon. - Fri. (8am - 5pm) CST.Call your doctor for medical advise about side effects.  Serious side effects associated with this product may be reported to this number.

Product Packaging:



Packaging below represents the labeling currently used:Principal display panel and side panel for 473 mL label:NDC 23359-023-16Rydex LiquidAntihistamine/Antitussive/Nasal DecongestantSugar Free/Alcohol FreeEach 5mL (ONE TEASPOONFUL) FOR ORAL ADMINISTRATION CONTAINS:Brompheniramine Maleate..............................1.33 mgCodeine Phosphate........................................6.33 mg(WARNING:  May be habit-forming.)Pseudoephedrine Hydrochloride.........................10 mgCVCotton Candy FlavorCenturion Labs, LLCLeading Pharmaceuticals16 fl. oz. (473 mL)Tamper evident by foil seal under cap.  Do not use if foil seal is broken or missing.Dispense in a tight, light-resistant container, as defined in the USP/NF, with a child resistant cap.This package not intended for dispensing to the patient.Store at 59° - 86°F(15° - 30°C)Manufactured for:Centurion Labs, LLCBirmingham, AL 35243Rev. 04/10

* Please review the disclaimer below.