Otc - Active Ingredient
Diphenhydramine HCl 25 mg
Diphenhydramine Hcl Tablet, Film Coated
FDA Label NDC 73376-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Invahealth Inc for the product Diphenhydramine Hcl (NDC 73376-003). 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 - when using, otc - ask doctor, otc - ask doctor/pharmacist, otc - pregnancy or breast feeding, otc - keep out of reach of children, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antihistamine
Otc - When Using
Do not use • to make a child sleepy • with any other product containing diphenhydramine, even one used on skin
Otc - Ask Doctor
a breathing problem such as emphysema or chronic bronchitis • glaucoma • trouble urinating due to an enlarged prostate gland
Otc - Ask Doctor/Pharmacist
taking sedatives or tranquilizers
Otc - Pregnancy Or Breast Feeding
ask a health professional before use.
Otc - 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)
Otc - Questions
609-642-6380
Inactive Ingredient
Colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C Red No. 3, magnesium stearate, microcrystalline cellulose, polyethylene glycol, hydroxy propyl methyl cellulose talc, titanium dioxide
Dosage & Administration
take every 4 to 6 hours do not take more than 6 doses in 24 hours
adults & children 12 years & over 1 to 2 tablets
children 6 to under 12 years 1 tablet
children under 6 years do not use this product in children under 6 years of age
Warnings
Do not use
to make a child sleepy
with any other product containing diphenhydramine, even one used on skin
Indications & Usage
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
runny nose
sneezing
itchy, watery eyes
itching of the nose or throat
temporarily relieves these symptoms due to the common cold:
runny nose
sneezing
* Please review the disclaimer below.
