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Drug Facts
Allergy Relief
FDA Label NDC 36800-669
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Allergy Relief (NDC 36800-669). 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 other, active ingredient (in each tablet), purpose, uses, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, 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
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 You Have
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- glaucoma
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you 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
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. 1(800)222-1222
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 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
- each tablet contains: calcium 25 mg
- store at controlled room temperature 20°-25°C (68°-77°F)
- protect from moisture and light
- see end flap for expiration date and lot number
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, D&C red No 27 aluminum lake, dicalcium phosphate, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide
Questions Or Comments?
1-888-333-9792
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TopCare health Allergy Relief,
100 Tablets
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