Active Ingredient (In Each Capsule)
Diphenhydramine HCl 50 mg
Nighttime Sleep-aid Capsule, Liquid Filled
FDA Label NDC 69452-451
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bionpharma Inc. for the product Nighttime Sleep-aid (NDC 69452-451). 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 capsule), purpose, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use, 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
Purpose
Nighttime sleep-aid
Uses
- For relief of occasional sleeplessness
- reduces time to fall asleep if you have difficulty falling asleep
Warnings
Do not use
- for children under 12 years of age
- with any 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 you are taking sedatives or tranquilizers.
When Using This Product
- avoid alcoholic beverages
- be careful when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
sleeplessness persists continuosly for more than 2 weeks, consult your doctor.
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.
In case of overdose, get medical help or contact a Poison Control Centre right away.
Directions
- Adults and children 12 years of age and over:One softgel (50 mg) at bedtime if needed, or as directed by a doctor.
- swallow whole; do not crush, chew, or dissolve
Other Information
- store at 20 oC to 25 oC (68 oF to 77 oF)
- avoid high humidity and excessive heat above 40 oC (104 oF).
- protect from light
Inactive Ingredients
gelatin, glycerin, polyethylene glycol 400, polyethylene glycol 600, propylene glycol, purified water, sorbitol sorbitan solution
Questions Or Comments?
1-888-235-2466(Mon-Fri 9AM-5PM EST)
Other
†This product is not manufactured or distributed by the owners of Unisom® SleepGels®.
DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.
Manufactured for:
Bionpharma Inc.
Princeton, NJ 08540
Made in India
Mfg. Lic. No.: TN00002123
L0000862
R0524
2620535
Lot No.:
Exp. Date:
120'S Count
†Compare to the active ingredient in Unisom® SleepGels®
NDC 69452-451-22
a+ health TM
maximum strength
nighttime
sleep-aid
dye
free
diphenhydramine HCl capsules USP, 50 mg
• fall asleep fast
• sleep soundly
• safe, non-habit
forming
one softgel per dose
120 softgels**
**liquid-filled capsules
Front (Front)
Back (Back)
* Please review the disclaimer below.
