Rydex

Dosage form: liquid
Ingredients: Brompheniramine Maleate 1.33mg in 5mL, Codeine Phosphate 6.33mg in 5mL, Pseudoephedrine Hydrochloride 10mg in 5mL
Labeler: Centurion Labs
NDC Code: 23359-023

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.

Rydex Liquid

Drug Facts Active ingredients                                                          Purpose
(in each 5 mL teaspoonful)

Brompheniramine Maleate 1.33 mg..................................................Antihistamine
Codeine Phosphate*6.33 mg............................................................Antitussive
                                                                                           (Cough Suppressant)
*WARNING:  May be habit forming
Pseudoephedrine Hydrochloride 10 mg.............................................Nasal Decongestant

Usestemporarily 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 aretaking 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 informationEach 5 mL (one teaspoonful) contains:  sodium 2 mg
Store at 59° - 86°F (15° - 30°C)

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

Questions? Comments?Call 1-866-959-4880
Mon. - 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 23359-023-16

Rydex Liquid

Antihistamine/Antitussive/Nasal Decongestant

Sugar Free/Alcohol Free

Each 5mL (ONE TEASPOONFUL) FOR ORAL ADMINISTRATION CONTAINS:

Brompheniramine Maleate..............................1.33 mg
Codeine Phosphate........................................6.33 mg
(WARNING:  May be habit-forming.)
Pseudoephedrine Hydrochloride.........................10 mg

CV

Cotton Candy Flavor

Centurion Labs, LLC
Leading Pharmaceuticals

16 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, LLC
Birmingham, AL 35243

Rev. 04/10














RYDEX 
brompheniramine maleate, codeine phosphate, pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:23359-023
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Brompheniramine Maleate (Brompheniramine) Brompheniramine Maleate1.33 mg  in 5 mL
Codeine Phosphate (Codeine) Codeine Phosphate6.33 mg  in 5 mL
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride10 mg  in 5 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorCOTTON CANDYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:23359-023-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/14/2010
Labeler - Centurion Labs (806756461)

Revised: 06/2010
 
Centurion Labs

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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