FDA Label for Sleepaid (diphenhydramine Hcl)
View Indications, Usage & Precautions
Sleepaid (diphenhydramine Hcl) Product Label
The following document was submitted to the FDA by the labeler of this product Apnar Pharma Lp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts
Active ingredient (in each soft gel)
Diphenhydramine HCL 50 mg
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.