Active Ingredient(S)
Chlorpheniramine Maleate 4 mg
Allergy Relief Tablet
FDA Label NDC 50804-277
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Good Sense for the product Allergy Relief (NDC 50804-277). 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(s), purpose, use(s), ask a doctor before use if, ask a doctor or pharmacist before use if, when using this product, pregnancy/breastfeeding, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
Use(S)
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- sneezing
- runny nose
- itchy, watery eyes
- itching of the nose or throat
Ask A Doctor Before Use If
- 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
- marked drowsiness may occur
- avoid alcoholic beverages
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur especially in children
Pregnancy/Breastfeeding
If pregnant or breast-feeding, ask a health professional before use.
Keep Out Of Reach Of Children
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222)
right away.
Directions
Adults and children 12 years and over: 1 tablet every 4 to 6 hours, not to exceed 6 tablets in 24 hours
Children 6 to under 12 years of age: ½ tablet (break tablet in half) every 4 to 6 hours, not to exceed 3 whole tablets in 24 hours
Children under 6 years of age: ask a doctor
Other Information
- Store between 20°-25°C (68°-77°F)
- Do not use if blister is unit is torn or open
Inactive Ingredients
D&C yellow #10 aluminum lake, lactose, magnesium stearate, microcrystalline cellulose, stearic acid
Questions
Questions or Comments? 1-888-952-0050 (Monday-Friday 9AM-5PM EST)
Principal Display Panel
Allergy Relief (277 Allergy Relief 1)
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