Diphenhydramine Hydrochloride Tablet
FDA Label NDC 37835-641

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bi-mart for the product Diphenhydramine Hydrochloride (NDC 37835-641). 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, warnings, if pregnant or breast-feeding,, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient (in Each Tablet)

→ Purpose

→ Uses

→ Warnings

→ If Pregnant Or Breast-feeding,

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Principal Display Panel

Active Ingredient (In Each Tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

o runny nose

o sneezing

o itchy, watery eyes

o itchy of the nose or throat

temporarily relieves these symptoms of the common cold:

o runny nose
o sneezing

Warnings

Do not use

to make a child sleepy
with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

glaucoma
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if youaretaking sedatives or tranquilizers

When using this product

marked drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives and othe tranquilizers may increase drowsiness
use caution when driving a motor vehicle or operating machinery
excitability may occur, especially in children

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 (1-800-222-1222) right away.

Directions

take every 4 to 6 hours, or as directed by a doctor
do not take not more than 6 times in 24 hours

adults and children 12 years and over:1 or 2 tablets
children 6 to under 12 years:1 tablet
children under 6 years:do not use

Other Information

each tablet contains:calcium 30 mg
each tablet contains:phosphorus 15 mg
store at room temperature
protct from moisture
DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.

Inactive Ingredients

Colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, phloxine B lake, polyethylene glycol, polyvinyl alcohol, stearic acid, talc, titanium dioxide.