Active Ingredient
Chlorpheniramine maleate 4 mg
Chlorpheniramine Maleate
FDA Label NDC 67046-089
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Contract Pharmacy Services-pa for the product Chlorpheniramine Maleate (NDC 67046-089). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
Uses
- temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy nose or throat
- itchy, watery eyes
Do Not Use
to make a child sleepy
Ask A Doctor Before Use If You Have
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers
When Using This Product
- alcohol, sedatives and tranquilizers may increase drowsiness
- drowsiness may occur
- avoid alcoholic drinks
- excitability may occur, especially in children
- be careful when driving a motor vehicle or operating machinery
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.
Directions
take every 4 to 6 hours, not more than 6 doses in 24 hours
| adults and children 12 years of age and over | 1 tablet (4 mg) |
| children 6 to under 12 years of age | 1/2 tablet (2 mg) |
| children 4 to under 6 years of age | do not use unless directed by a doctor |
| children under 4 years of age | do not use |
Inactive Ingredients
D&C yellow #10 lake, lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch.
Questions Or Comments?
Distributed by:
Major Pharmaceuticals
31778 Enterprise Drive
Livonia, MI 48150, USA
1-734-743-6000
Repackaged by:
Contract Pharmacy Services-PA
125 Titus Ave Suite 200
Warrington, PA 18976 USA
Original--01/2011--NJW
Package/Label Principal Display Panel
Blister of 30 Tablets
* Please review the disclaimer below.
