Label: RYDEX- brompheniramine maleate, codeine phosphate, pseudoephedrine hydrochloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 23359-023-16 - Packager: Centurion Labs
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: CV
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated June 11, 2010
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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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
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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
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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
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
- 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.
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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
- Inactive ingredients
- Questions? Comments?
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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
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INGREDIENTS AND APPEARANCE
RYDEX
brompheniramine maleate, codeine phosphate, pseudoephedrine hydrochloride liquidProduct 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)