CERON DM - chlorpheniramine maleate, phenylephrine hydrochloride and dextromethorphan hydrobromide syrup
Cypress Pharmaceutical, Inc.

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.

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Drug Facts

Active ingredients
(in each 5 mL teaspoonful)
Chlorpheniramine Maleate 4 mg
Phenylephrine Hydrochloride 12.5 mg
Dextromethorphan Hydrobromide 15 mg

Purpose

Antihistamine
Decongestant
Antitussive

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

runny nose
sneezing
itching of the nose or throat
itchy, water eyes
nasal congestion
reduces swelling of the nasal passages
cough due to minor throat and bronchial irritation

Warnings

Do not exceed recommended dosage.

Do not use this product

if you are now taking a prescription monoamie 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 breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland
heart disease
high blood pressure
thyroid disease
diabetes mellitus
a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
a cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

excitability may occur, especially in children
you may get drowsy
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.
new symptoms occur

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of the reach of children.

In case of accidental overdose seek medical help or contact a Poison Control Center immediately.

Directions

Do not exceed recommended dosage.

Adults and children 12 years of age and older:	1 teaspoonful (5 mL) every 6 hours, not to exceed 4 teaspoonfuls in 24 hours.
Children 6 to under 12 years of age:	1/2 teaspoonfuls every 6 hours, not to exceed 2 teaspoonfuls in 24 hours.
Children under 6 years of age:	Consult a physician.

Other information

Store at 68°- 77°F(20°- 25°C)

Inactive ingredients

FD and C Blue #1, FD and C Red #40, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

Questions? Comments?

1-800-856-4393
M-F: 8:00 a.m.- 5:00 p.m. CT
Serious side effects associated with use of this product may be reported to this number.

Manufactured for:
Cypress Pharmaceuticals, Inc.
Madison, MS 39110

I297 Rev. 03/09

Product Packaging

The packaging below represents the labeling currently used:

Principal display panel and side panel for 473 mL label:

NDC 60258-415-16

CERON-DM
Syrup

Antihistamine/Decongestant
Antitussive

Each teaspoonful (5 mL) for oral administration
contains:
Chlorpheniramine Maleate...........................4.0 mg
Phenylephrine HCl....................................12.5 mg
Dextromethorphan HBr..............................15.0 mg

Grape Flavor

Sugar Free/Alcohol Free

CYPRESS
PHARMACEUTICAL, INC.

16 fl oz (473 mL)

Tamper evident by foil seal under cap. Do not use if foil
seal is broken or missing.

Supplied in a tight, light-resistant container with a
child-resistant cap.

THIS BOTTLE NOT TO BE DISPENSED TO THE CONSUMER.

Mfg. for: Cypress Pharmaceutical, Inc.
Madison, MS 39110

L591 Rev. 03/09

CERON DM
chlorpheniramine maleate, phenylephrine hydrochloride, dextromethorphan hydrobromide syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60258-415
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Chlorpheniramine Maleate (Chlorpheniramine)	Chlorpheniramine Maleate	4.0 mg in 5 mL
Phenylephrine Hydrochloride (Phenylephrine)	Phenylephrine Hydrochloride	12.5 mg in 5 mL
Dextromethorphan Hydrobromide (Dextromethorphan)	Dextromethorphan Hydrobromide	15.0 mg in 5 mL

Inactive Ingredients
Ingredient Name	Strength
Glycerin
Propylene Glycol
Water
Sodium Citrate
Saccharin Sodium
Sorbitol

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:60258-415-16	473 mL in 1 BOTTLE	None
2	NDC:60258-415-04	118 mL in 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/01/2006	08/26/2011

Labeler - Cypress Pharmaceutical, Inc. (790248942)

Revised: 08/2011 Cypress Pharmaceutical, Inc.