CERON-DM Syrup

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:

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 Packaging


CERON-DM Packaging



CERON  DM
chlorpheniramine maleate, phenylephrine hydrochloride, dextromethorphan hydrobromide syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60258-415
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chlorpheniramine Maleate (Chlorpheniramine) Chlorpheniramine Maleate4.0 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride12.5 mg  in 5 mL
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide15.0 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Glycerin 
Propylene Glycol 
Water 
Sodium Citrate 
Saccharin Sodium 
Sorbitol 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:60258-415-16473 mL in 1 BOTTLENone
2NDC:60258-415-04118 mL in 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/200608/26/2011

Labeler - Cypress Pharmaceutical, Inc. (790248942)

Revised: 08/2011 Cypress Pharmaceutical, Inc.