Label at a glance#

ProductRydex

Active ingredientBrompheniramine Maleate, Codeine Phosphate, Pseudoephedrine Hydrochloride

Label structure8 sections

Indications and 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

Dosage and administration

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.

Storage and handling

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

Contacts and useful links#

PhoneLabel contact1-866-959-4880

Label contents#

Full prescribing information#

Drug Facts

OTC - PURPOSE SECTION

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

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Do not exceed recommended dosage.

Do not use this product

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions? Comments?

OTC - QUESTIONS SECTION

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:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
994289	codeine phosphate 6.33 MG / brompheniramine maleate 1.33 MG / pseudoephedrine HCl 10 MG in 5 mL Oral Solution	PSN	1
994289	brompheniramine maleate 0.27 MG/ML / codeine phosphate 1.27 MG/ML / pseudoephedrine hydrochloride 2 MG/ML Oral Solution	SCD	1
994289	brompheniramine maleate 1.33 MG / codeine phosphate 6.33 MG / pseudoephedrine hydrochloride 10 MG per 5 ML Oral Solution	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
PSEUDOEPHEDRINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
09d8330d-4fec-be98-3a66-f985140646b2	Product name	2	20210513
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
20c8cafe-5cfc-44f8-a9be-a664f437f780	Product name	2	20200225
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
c0200ab5-4954-454e-9676-30b741b245bd	Product name	1	20150730
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
2a21311a-89e2-0e83-2ebd-117f9798b2b2	Product name	1	20140508
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
47fd879b-91c5-e1e5-130f-29d082a871ec	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
23359-023-16	2019-10-21	C162847	48780-1	956f9ecf-bc1c-621f-e053-dbdaa90a74ad	Rydex Liquid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
23359-023-16	Rydex	473 mL in 1 BOTTLE	LIQUID	473		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
23359-023	RYDEX (BROMPHENIRAMINE MALEATE, CODEINE PHOSPHATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [CENTURION LABS]	1	Legacy NDC, 1 package rows	20100621_9751b120-49d4-46dd-82cc-638412b5f86d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
23359-023-16	ML - Milliliter	23359-023	b8022053-d0e0-4ab3-b05f-e3276ffb4b2b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Brompheniramine Maleate	ACTIVE INGREDIENT	IXA7C9ZN03	1
Codeine Phosphate	ACTIVE INGREDIENT	GSL05Y1MN6	1
Pseudoephedrine Hydrochloride	ACTIVE INGREDIENT	6V9V2RYJ8N	1
Brompheniramine	ACTIVE MOIETY	H57G17P2FN	1
Codeine	ACTIVE MOIETY	Q830PW7520	1
Pseudoephedrine	ACTIVE MOIETY	7CUC9DDI9F	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

Rydex
Brompheniramine Maleate, Codeine Phosphate, Pseudoephedrine Hydrochloride
Brompheniramine Maleate
Brompheniramine
Codeine Phosphate
Codeine
Pseudoephedrine Hydrochloride
Pseudoephedrine

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
23359-023	23359-023-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Brompheniramine Maleate	IXA7C9ZN03	ACTIB
Codeine Phosphate	GSL05Y1MN6	ACTIB
Pseudoephedrine Hydrochloride	6V9V2RYJ8N	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
03a0c43b-b783-44a6-a9ff-ad862fb95a82			9751b120-49d4-46dd-82cc-638412b5f86d	2010-06-11	Warnings	Exact identifier spl id: 03a0c43b-b783-44a6-a9ff-ad862fb95a82 spl set id: 9751b120-49d4-46dd-82cc-638412b5f86d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.