Package Insert and Label Information: Leader Sinus and Allergy PE
LEADER SINUS AND ALLERGY PE- chlorpheniramine maleate and phenylephrine hydrochloride tablet, film coated
Cardinal Health
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 ingredient (in each tablet)
Chlorpheniramine maleate 4 mg
Phenylephrine HCl 10 mg
Purpose
Antihistamine
Nasal decongestant
Uses
- temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- nasal congestion
- itching of the nose or throat
- sinus congestion and pressure
Warnings
Do not use
- 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 pharmacist before taking this product.
- to make a child sleepy
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers
When using this product
- do not use more than directed
- excitability may occur, especially in children
- drowsiness may occur
- alcohol, sedatives and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- you get nervous, dizzy or sleepless
- symptoms do not get better within 7 days or occur with fever
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Directions
| adults and children 12 years and over |
|
| children under 12 years | do not use this product in children under 12 years of age |
Other information
- store at 20°-25°C (68°-77°F)
Inactive ingredients
carnauba wax, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide
Questions or comments}?
1-800-719-9260
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Compare to Sudafed PE® Sinus & Allergy active ingredients
Maximum Strength
Sinus & Allergy PE
Chlorpheniramine Maleate, Antihistamine
Phenylephrine HCl, Nasal Decongestant
Sinus Pressure
Sinus & Nasal Congestion
Sneezing
Itchy, Watery Eyes
# Doses
1 Pill/Dose
Sinus and Allergy PE Carton
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| Labeler — Cardinal Health (097537435) |
Revised: 10/2006 Cardinal Health
