Drug Facts
Active ingredient (in each soft gel)
Diphenhydramine HCL 50 mg
Sleepaid (diphenhydramine Hcl) Capsule, Liquid Filled
FDA Label NDC 24689-154
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Apnar Pharma Lp for the product Sleepaid (diphenhydramine Hcl) (NDC 24689-154). 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 drug facts, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Nighttime sleep-aid
Indications & Usage
USES
Use for relief of occasional sleeplessness.
Warnings
Warnings
Do not use
- for children under 12 years of age
- with any other products containing diphenhydramine, even one used on skin.
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland.
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers.
When using this product
avoid alcoholic drinks
Stop use and ask a doctor if
sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
If pregnant or breast-feeding,
ask a health professional before use.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF THE 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
adults and children 12 years of age and over: Take 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor
Storage And Handling
Other information
- store at room temperature 15° to 30° C (59° to 86° F)
- avoid excessive heat
- do not use if imprinted safety seal under cap is broken or missing
Inactive Ingredient
Inactive Ingredients
FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution, white ink
Otc - Questions
Questions or comments?
- Call 1-855-642-2594
Other
*Compare to active ingredient in Unisom ® SleepGels ®
*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom ®
Rev.: 03/2023
Manufactured by:
Apnar Pharma LLP
East Windsor, NJ 08520
Package Label.Principal Display Panel
NDC 24689-154-01
SleepAid
Diphenhydramine HCL 50 mg
- Safe, non habit-forming
- One softgel per dose
Made in USA
100 Soft gels
* Please review the disclaimer below.
