Active Ingredient(S)
Diphenhydramine HCl 25 mg
Allergy Relief Tablet
FDA Label NDC 50804-048
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 50804-048). 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), do not use, ask a doctor before use if, ask a doctor or pharmacist before use if, when using this product, if pregnant or breastfeeding,, 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:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
- sneezing
- runny nose
temporarily relieves these symptoms due to the common cold:
Do Not Use
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
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
are taking sedatives or tranquilizers
When Using This Product
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
If Pregnant Or Breastfeeding,
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
take every 4 to 6 hours, or as directed by a doctor
do not take more than 6 times in 24 hours
adults and children 12 years and over: 1 to 2 tablets
children 6 to under 12 years: 1 tablet
children under 6 years of age: do not use
Other Information
store at room temperature 20°– 25°C (68°– 77°F)
Inactive Ingredients
croscarmellose sodium, D&C red #27 aluminum lake, hypromellose, lactose, magnesium
stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide
Questions/Comments
Call 1-888-952-0050 (Monday-Friday 9AM-5PM EST)
Principal Display Panel
Allergy Relief
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