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.
Active ingredients (in each 5 mL teaspoonful) Chlorpheniramine Maleate 4 mg Phenylephrine Hydrochloride 12.5 mg Dextromethorphan Hydrobromide 15 mg
Antihistamine Decongestant Antitussive
temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
itching of the nose or throat
itchy, water eyes
reduces swelling of the nasal passages
cough due to minor throat and bronchial irritation
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
trouble urinating due to an enlarged prostate gland
high blood pressure
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.
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.
Store at 68°- 77°F(20°- 25°C)
FD and C Blue #1, FD and C Red #40, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.
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
The packaging below represents the labeling currently used:
Principal display panel and side panel for 473 mL label:
Each teaspoonful (5 mL) for oral administration contains: Chlorpheniramine Maleate...........................4.0 mg Phenylephrine HCl....................................12.5 mg Dextromethorphan HBr..............................15.0 mg
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