Active Ingredient (In Each Tablet)
Diphenhydramine HCl 25 mg
The following Structured Product Label (SPL) was submitted to the FDA by Morning Star Otc for the product Benadryl (NDC 53209-3001). 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 (in each tablet), purpose, uses, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Diphenhydramine HCl 25 mg
Antihistamine
Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers
If pregnant or breast-feeding, 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 right away. (1-800-222-1222)
| adults and children 12 years and over | 1 to 2 tablets |
| children 6 to under 12 years | 1 tablet |
| children under 6 years | do not use |
carnauba wax, croscarmellose sodium, D&C red no. 27 aluminum lake, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide
call 1-877-717-2824(toll-free) or 215-273-8755(collect)
* Please review the disclaimer below.