Active Ingredient (In Each Tablet)
Diphenhydramine HCl 25 mg
Sleep Tabs Tablet
FDA Label NDC 0904-4274
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Sleep Tabs (NDC 0904-4274). 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 tablet), purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, 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
Do Not Use
- with any other product containing diphenhydramine, even one used on skin
- for children under 12 years of age
Ask A Doctor Before Use If You Have
- a breathing problem such as emphysema or chronic bronchitis
- difficulty in urination due to enlargement of the prostate gland
- glaucoma
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers.
When Using This Product
avoid alcoholic beverages.
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.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not take more than directed
- adults and children 12 years and over: take 2 tablets at bedtime if needed or as directed by a doctor
- children under 12 years: do not use
Other Information
- each tablet contains: calcium 60 mg
- protect from moisture
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive Ingredients
croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid
Questions Or Comments?
(800) 616-2471
Principal Display Panel
MAJOR®
NDC 0904-4274-51
Compare to the active ingredient in Original Formula Sominex®*
Sleep Tabs
Diphenhydramine HCl
25 mg
Nighttime Sleep-Aid
Actual Size
50 Tablets
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by Medtech Products Inc., owner of the registered trademark Original Formula Sominex®.
50844 REV1019N18915
Distributed by:
MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive
Suite 233, Livonia, MI 48152
Rev. 01/20 M-17 Re-order No. 700607
Major 44-189 (Major 44 189 1)
* Please review the disclaimer below.
