Active Ingredient (In Each Tablet)
Chlorpheniramine maleate 4 mg
Allergy Tablet
FDA Label NDC 50090-0049
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by A-s Medication Solutions for the product Allergy (NDC 50090-0049). 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 (in each tablet), 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 due to hay fever or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- sneezing
- itching of the nose or throat
Do Not Use
to make a child sleepy.
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
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers.
When Using This Product
- drowsiness may occur
- avoid alcoholic beverages
- alcohol, sedatives, and tranquilizers may increase drowsiness
- use caution when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
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 (1-800-222-1222) right away.
Directions
| adults and children 12 years of age and over | 1 tablet every 4 to 6 hours. Do not take more than 6 tablets in 24 hours. |
| children 6 to under 12 years of age | 1/2 tablet (break tablet in half) every 4 to 6 hours. Do not exceed 3 whole tablets in 24 hours. |
| children under 6 years of age | do not use this product in children under 6 years of age |
Other Information
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- protect from excessive moisture
- see end flap for expiration date and lot number
Inactive Ingredients
corn starch, D&C yellow #10 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose
Questions Or Comments?
(800) 616-2471
How Supplied
Product: 50090-0049
NDC: 50090-0049-6 20 TABLET in a BOTTLE
NDC: 50090-0049-7 60 TABLET in a BOTTLE
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