Other
Drug Facts
Nighttime Sleep Aid Capsule, Liquid Filled
FDA Label NDC 68391-613
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bjwc (berkley & Jensen / Bj's) for the product Nighttime Sleep Aid (NDC 68391-613). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient (in each softgel)
Diphenhydramine HCl 25 mg
Otc - Purpose
Purpose
Nighttime sleep-aid
Indications & Usage
Uses
- for the relief of occasional sleeplessness
- reduces time to fall asleep if you have difficulty falling asleep
Warnings
Warnings
Otc - Do Not Use
Do not use
- for children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin.
Otc - Ask Doctor
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
Otc - When Using
When using this product
- avoid alcoholic beverages
Otc - Stop Use
Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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.
Dosage & Administration
Directions
- take only one dose (2 softgels) per day (24 hours)
adults & children 12 yrs & over | 2 softgels at bedtime if needed or as directed by a doctor |
children under 12 yrs | do not use |
Other Safety Information
Other information
- store at 20-25° C (68-77°F)
- avoid excessive heat above 40°C (104°F)
- protect from light.
Inactive Ingredient
Inactive ingredients
FD&C blue no. 1, FD&C red no. 40, gelatin, glycerol, polyethylene glycol 400, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide.
Otc - Questions
Questions or comments? Call 1-877-290-4008
* Please review the disclaimer below.
