RYDEX- brompheniramine maleate, codeine phosphate, pseudoephedrine hydrochloride liquid

Rydex by

Drug Labeling and Warnings

Rydex by is a Otc medication manufactured, distributed, or labeled by Centurion Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 ageand 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.

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

INGREDIENTS AND APPEARANCE

RYDEX 
brompheniramine maleate, codeine phosphate, pseudoephedrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 23359-023
Route of Administration	ORAL	DEA Schedule	CV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Brompheniramine Maleate (UNII: IXA7C9ZN03) (Brompheniramine - UNII:H57G17P2FN)	Brompheniramine Maleate	1.33 mg  in 5 mL
Codeine Phosphate (UNII: GSL05Y1MN6) (Codeine - UNII:Q830PW7520)	Codeine Phosphate	6.33 mg  in 5 mL
Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F)	Pseudoephedrine Hydrochloride	10 mg  in 5 mL

Product Characteristics
Color		Score
Shape		Size
Flavor	COTTON CANDY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23359-023-16	473 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/14/2010

Labeler - Centurion Labs (806756461)