Otc - Active Ingredient
Diphenhydramine Hydrochloride 25 mg
Diphenhydramine Hydrochloride Tablet, Film Coated
FDA Label NDC 51662-1674
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hf Acquisition Co Llc, Dba Healthfirst for the product Diphenhydramine Hydrochloride (NDC 51662-1674). 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, uses, warnings, directions, other safety information, inactive ingredient, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antihistamine
Uses
Temporarily relieves these symptoms due to hay fever or other respiratory allergies
runny nose
sneezing
itching of the nose or throat
itchy, watery eyes
Temporarily relieves these symptoms due to the common cold
runny nose
sneezing
Warnings
Do not use – Diphen Allergy Caplet
to make a child sleepy
with any other product containing diphenhydramine, even one that is used on skin.
Ask a doctor before use if you have – Diphen Allergy Caplet
a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to an enlarged prostate gland
glaucoma
Ask a doctor or pharmacist before use if you are – Diphen Allergy Caplet
taking sedatives or tranquilizers
When using this product – Diphen Allergy Caplet
marked drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives and tranquilizers may increase the drowsiness effect
use caution when driving a motor vehicle or operating machinery
excitability may occur, especially in children
If pregnant or breast-feeding, – Diphen Allergy Caplet
ask a health care professional before use.
Keep out of reach of children. – Diphen Allergy Caplet
In case of overdose, contact a physician or poison control center right away (1-800-222-1222).
Directions
Do not use – Diphen Allergy Caplet
to make a child sleepy
with any other product containing diphenhydramine, even one that is used on skin.
Ask a doctor before use if you have – Diphen Allergy Caplet
a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to an enlarged prostate gland
glaucoma
Ask a doctor or pharmacist before use if you are – Diphen Allergy Caplet
taking sedatives or tranquilizers
When using this product – Diphen Allergy Caplet
marked drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives and tranquilizers may increase the drowsiness effect
use caution when driving a motor vehicle or operating machinery
excitability may occur, especially in children
If pregnant or breast-feeding, – Diphen Allergy Caplet
ask a health care professional before use.
Keep out of reach of children. – Diphen Allergy Caplet
In case of overdose, contact a physician or poison control center right away (1-800-222-1222).
Other Safety Information
protect from light
store at room temperature 68°-77°F (20°-25°C)
tamper-evident sealed packets
do not use any opened or torn packets
Inactive Ingredient
croscarmellose sodium, D&C red #27 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide
Otc - Keep Out Of Reach Of Children
KEEP OUT OF THE REACH OF CHILDREN
Otc - Do Not Use
Do not use – Diphen Allergy Caplet
to make a child sleepy
with any other product containing diphenhydramine, even one that is used on skin.
Otc - Ask Doctor
Ask a doctor before use if you have – Diphen Allergy Caplet
a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to an enlarged prostate gland
glaucoma
Ask a doctor or pharmacist before use if you are – Diphen Allergy Caplet
taking sedatives or tranquilizers
Otc - When Using
When using this product – Diphen Allergy Caplet
marked drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives and tranquilizers may increase the drowsiness effect
use caution when driving a motor vehicle or operating machinery
excitability may occur, especially in children
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, – Diphen Allergy Caplet
ask a health care professional before use.
Dosage & Administration
Temporarily relieves these symptoms due to hay fever or other respiratory allergies
runny nose
sneezing
itching of the nose or throat
itchy, watery eyes
Temporarily relieves these symptoms due to the common cold
runny nose
sneezing
Indications & Usage
Temporarily relieves these symptoms due to hay fever or other respiratory allergies
runny nose
sneezing
itching of the nose or throat
itchy, watery eyes
Temporarily relieves these symptoms due to the common cold
runny nose
sneezing
* Please review the disclaimer below.
