Nightime Sleep Aid Capsule, Liquid Filled
FDA Label NDC 76168-065

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Velocity Pharma for the product Nightime Sleep Aid (NDC 76168-065). 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, directions, warnings, keep out of reach of children., 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

→ Directions

→ Warnings

→ Keep Out Of Reach Of Children.

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments

→ Package Label.principal Display Panel

Active Ingredient

(in each softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep aid

Uses

For relief of occasional sleeplessness.

Directions

adults and children 12 years and over : one softgel (50 mg) at bed time if needed or as directed by a doctor.
children under 12 years:do not use

Warnings

Do not use

in children under 12 years of age.
with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
glaucoma
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema or chronic bronchitis
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
When using this product
avoid alcoholic drinks
If pregnant or breast-feeding, ask a health professional before use.