Allergy Relief Tablet, Film Coated
FDA Label NDC 0363-9024
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Allergy Relief (NDC 0363-9024). 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 durg facts, active ingredient (in each tablet), purpose, uses, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Tablet)
Diphenhydramine HCl 25 mg
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
• temporarily relieves these symptoms due to the common cold:
• runny nose
• sneezing
Otc - Do Not Use
Do not use
• to make a child sleepy
• with any other product containing diphenhydramine, even one used on skin
Otc - Ask Doctor
Ask a doctor before use if you have
• a breathing problem such as emphysema or chronic bronchitis
• trouble urinating due to an enlarged prostate gland n glaucoma
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
Otc - When Using
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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
- do not take more than 6 doses in 24 hours
| adults and children 12 years of age and over | 1 to 2 tablets |
| children 6 to under 12 years of age | 1 tablet |
| children under 6 years of age | do not use this product in children under 6 years of age |
Other Information
- store at controlled room temperature 15°-30° C (59°-86° F)
- protect from moisture and light
- see end flap for expiration date and lot number
- each tablet contains calcium 24 mg
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C red # 27 Al lake, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide
Questions Or Comments?
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