CERON SYRUP
-
chlorpheniramine maleate and
phenylephrine hydrochloride syrup
Cypress Pharmaceutical, Inc.
----------
CERON SyrupDrug Facts
Active ingredients Purpose
(in each 5 mL teaspoonful)
Chlorpheniramine Maleate 4 mg........................Antihistamine
Phenylephrine Hydrochloride 12.5 mg............... Decongestant
Uses
temporarily relieves these symptoms due to the common cold, hay fever
(allergic rhinitis) or other respiratory allergies:
•runny nose •sneezing •itching of the nose or throat •itchy, watery eyes
•nasal congestion •reduces swelling of nasal passages
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 pharmaicst before
taking this product
Ask a doctor before use if you have
•a breathing problem such as emphysema or chronic bronchitis •heart disease
•high blood pressure •thyroid disease •diabetes mellitus •glaucoma
•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
•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
•if symptoms do not improve within 7 days or are accompanied by a fever.
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 professional 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 teaspoonful every 6 hours, not to exceed 2 teaspoonfuls in 24 hours. |
| Children under 6 years of age: | Consult a physician. |
Other information
Store at 68o - 77oF (20o - 25oC) excursions permitted to 15o - 30oC (59o-86oF)
Inactive ingredients
FD&C Red #40, Glycerin, Propylene Glycol, Purified Water, Raspberry Flavor, 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 Pharmaceutical, Inc.
Madison, MS 39110
I295 Rev. 03/09
PRODUCT PACKAGING
The packaging below represents the labeling currently used.NDC 60258-414-16
CERON Syrup
Antihistamine/Decongestant
Each teaspoonful (5 mL) for oral administration contains:
Chlorpheniramine Maleate....4.0 mg
Phenylephrine HCl.............12.5 mg
Raspberry 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 SHOULD NOT BE DISPENSED TO THE CONSUMER.
Mfg. for: Cypress Pharmaceutical, Inc., Madison, MS 39110
L589 Rev. 03/09
Ceron Syrup Packaging
| CERON SYRUP
chlorpheniramine maleate and phenylephrine hydrochloride syrup |
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph final | part341 | 01/16/2006 | |
| Labeler - Cypress Pharmaceutical, Inc. (790248942) |