Otc - Active Ingredient
Active Ingredients
Diphenhydramine HCl 25 mg
Allergy Antihistamine
FDA Label NDC 52904-460
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Select Corporation for the product Allergy Antihistamine (NDC 52904-460). 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 otc - active ingredient, otc - purpose, dosage & administration, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antihistamine
Dosage & Administration
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
caplets • Children 6 to under 12 years of age: 1
caplet • children under 6 years of age: do not use
this product in children under 6 years of age
Indications & Usage
Uses: • temporarily relieves these symptoms due to hay fever
or other upper respiratory allergies: • runny nose • sneezing
• itchy, watery eyes • itchy nose or throat • temporarily relieves
these symptoms due to the common cold: • runny nose
• sneezing
Warnings
Warnings: Do not use • to make a child sleepy• with any other product containing diphenhydramine, even oneused on skin Ask a doctor before use if you have: • abreathing problem such as emphysema or chronic bronchitis• glaucoma • trouble urinating due to an enlarged prostate glandAsk a doctor or pharmacist before use if you are: takingsedatives or tranquilizers When using this product: • markeddrowsiness may occur • avoid alcoholic drinks • alcohol,sedatives, and tranquilizers may increase drowsiness • becareful 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.
Inactive Ingredient
Inactive ingredients: carnauba wax,
colloidal silicon dioxide, croscarmellose sodium, DC red 27
aluminum lake, dibasic calcium phosphate dihydrate,
hydroxypropylmethyl cellulose, hypromellose, lactose,
magnesium stearate, microcrystalline cellulose, polyethylene
glycol (PEG) 400, polysorbate 80, silicon dioxide, titanium
dioxide
Package Label.Principal Display Panel
MM1
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