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 |
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Revised: 08/2011 Cypress Pharmaceutical, Inc.