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NDC 81522-0916-32 Sleep Aid 50 mg/1 Details
Sleep Aid 50 mg/1
Sleep Aid is a ORAL CAPSULE in the HUMAN OTC DRUG category. It is labeled and distributed by FSA Store Inc. (Caring Mills). The primary component is DIPHENHYDRAMINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
Related Packages: 81522-0916-32Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine
Product Information
NDC | 81522-0916 |
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Product ID | 81522-916_1472e3b5-4849-4e9b-94de-199b955ac92a |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | Sleep Aid |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Diphenhydramine HCL |
Product Type | HUMAN OTC DRUG |
Dosage Form | CAPSULE |
Route | ORAL |
Active Ingredient Strength | 50 |
Active Ingredient Units | mg/1 |
Substance Name | DIPHENHYDRAMINE HYDROCHLORIDE |
Labeler Name | FSA Store Inc. (Caring Mills) |
Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH FINAL |
Application Number | part338 |
Listing Certified Through | 2024-12-31 |
Package
Package Images

NDC 81522-0916-32 (81522091632)
NDC Package Code | 81522-916-32 |
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Billing NDC | 81522091632 |
Package | 1 BOTTLE, PLASTIC in 1 BOX (81522-916-32) / 32 CAPSULE in 1 BOTTLE, PLASTIC |
Marketing Start Date | 2021-10-08 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 9d32a3a1-9528-4de4-9fd1-1d01a1ad93e9 Details
Warnings
Do not use
- for children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
Directions
Inactive ingredients
Principal display panel
*Compare to the active ingredient in Unisom® SleepGels®
Sleep Aid
Diphenhydramine HCl 50 mg
Nighttime sleep aid
- Fall asleep fast
- Sleep soundly
- Wake up refreshed
Non-habit forming
Softgels
One Softgel per dose
†This product is not manufactured or distributed by Chattem, Inc., distributor of Unisom® SleepGels®.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
Manufactured for FSA Stores Inc.
240 W. 37th St. 6th Floor
New York, NY 10018
INGREDIENTS AND APPEARANCE
SLEEP AID
diphenhydramine hcl capsule |
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Labeler - FSA Store Inc. (Caring Mills) (049283340) |