Diphenhydramine Hcl
FDA Label NDC 58805-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Agile Pharmachem for the product Diphenhydramine Hcl (NDC 58805-001). 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, purpose, uses, warnings, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Package Label.principal Display Panel

Active Ingredient

(in each capsule)

Diphenhydramine HCl 25mg

Purpose

Sleep Aid

Uses

For the relief of occasional sleeplessness
Reduces time to fall asleep if have difficulty falling asleep

Warnings

Do not use

If children under 12 years of age
with any other product containing diphenhydramine, even one used on skin
with other drug that cause drowsiness such as antihistamines and nighttime cold/flu products
Do not use with generic NyQuil®

Ask a doctor before use if you have:

A breathing problem such as asthma, emphysema, or Chronic bronchitis
glaucoma
difficulty in urination due to enlargement of the prostate gland
heart disease
You are taking a diuretic
Ask a doctor or pharmacist before use if you are taking sedative or tranquilizers or any other sleep-aid, when using this product :
Avoid alcoholic beverages and other drugs that cause drowsiness
Drowsiness will occur
Be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks.
Insomnia may be a symptom of serious underlying medical illness.
If pregnant or breast-feeding, ask a health professional before use.

Keep Out Of Reach Of Children.

Overdose Warning: Taking more than directed can cause serious health problems, In case of overdose, get medical help or contact a Poison Control Center right away.