Otc - Active Ingredient
Active Ingredient (in each tablet)
Diphenhydramine HCI USP 25 mg
Benaldryl
FDA Label NDC 42787-104
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ajes Pharmaceuticals,llc for the product Benaldryl (NDC 42787-104). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Antihistamine
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children
In case of accidental overdose,
seek professional assistance or contact a Poison Control Center
Indications & Usage
Uses
-temporarily relieves these symptoms due to hay fever or upper
respiratory allergies: runny nose - sneezing - itchy, watery eyes
-itching of the nose and 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 one used on skin
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 or older - 1 to 2 tablets
children 6 years 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
Inactive Ingredient
Enter section text here
Package Label.Principal Display Panel
Copy Of Label (Dhp 25)
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