RYDEX (BROMPHENIRAMINE MALEATE, CODEINE PHOSPHATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [CENTURION LABS]

RYDEX (BROMPHENIRAMINE MALEATE, CODEINE PHOSPHATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [CENTURION LABS]
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NDC 23359-023-16
Set ID 9751b120-49d4-46dd-82cc-638412b5f86d
Category HUMAN OTC DRUG LABEL
Packager Centurion Labs
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number PART341
  • 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
  • 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 mg
    Store 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 1-866-959-4880
    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 Packaging



    Rydex Packaging









  • INGREDIENTS AND APPEARANCE
    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 (UNII: IXA7C9ZN03) (Brompheniramine - UNII:H57G17P2FN) Brompheniramine Maleate1.33 mg  in 5 mL
    Codeine Phosphate (UNII: GSL05Y1MN6) (Codeine - UNII:Q830PW7520) Codeine Phosphate6.33 mg  in 5 mL
    Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F) Pseudoephedrine Hydrochloride10 mg  in 5 mL
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCOTTON CANDYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    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)