Sleep Aid Capsule, Liquid Filled
FDA Label NDC 69168-431

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Sleep Aid (NDC 69168-431). 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(s), purpose, use(s), do not use, ask a doctor before use if, ask a doctor or pharmacist before use if, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient(s)

→ Purpose

→ Use(s)

→ Do Not Use

→ Ask A Doctor Before Use If

→ Ask A Doctor Or Pharmacist Before Use If

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Pregnancy/breastfeeding

→ Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Storage

→ Inactive Ingredients

→ Questions

→ Principal Display Panel

Active Ingredient(S)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Use(S)

for the relief of occasional sleeplessness
reduces time to fall asleep if you have difficulty falling asleep

Do Not Use

for children under 12 years of age
with any other product containing diphenhydramine, even one used on skin
with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

Ask A Doctor Before Use If

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

Ask A Doctor Or Pharmacist Before Use If

you are taking sedatives 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

if sleeplessness persists continuously for more than 2 weeks.

Insomnia may be a symptom of serious underlying medical illness.

Pregnancy/Breastfeeding

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