Sleep-EZ Nighttime Sleep Aid
- Dosage form
- TABLET, COATED
- Labeler
- Safrel Pharmaceuticals, LLC.
- Label updated
- 2021-05-31
- Retrieved
- 2026-09-07
- Active ingredients
- DIPHENHYDRAMINE HYDROCHLORIDE
Active ingredient (in each caplet)
Diphenhydramine HCl 25 mg
Purpose
Nighttime sleep-aid
Uses
provides relief of occasional sleeplessness
Warnings
Do not use
- for children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
- with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- glaucoma
-
heart disease
Ask a doctor or pharmacist before use if you are
taking sedative or tranquilizers or any other sleep-aid
When using this product
- drowsiness will occur
- avoid alcoholic beverages and other drugs that cause drowsiness
- excitability may occur, especially in children
- alcohol, sedatives and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
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.
Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not take more than directed (see overdose warning)
- adults and children 12 years of age and over: - take 2 caplets at bedtime if needed or as directed by a doctor
- children under 12 years of age: do not use
Other Information
- Each caplet contains: Calcium 23.52 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- read all product information before using
- TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Inactive Ingredients
Colloidal silicon dioxide, Croscarmellose sodium, Dicalcium phosphate, FD&C Blue #1, FD&C Blue #2, Magnesium stearate, Microcrystalline cellulose, Polyethylene glycol, Polyvinyl alcohol, Talc, Titanium dioxide
Questions or comments?
Call toll free 1-844-384-3723 Monday through Friday 9AM – 5PM EST or www.safrel.com
Principal Display Panel
Compare to Tylenol® Simply Sleep active ingredients*
* This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Simply Sleep®.
Diphenhydramine HCl Tablets, 25 mg
[Image in the official label — see DailyMed source]
DailyMed Set ID: 87537ba2-f4d7-8ea3-e053-2a95a90acc38 · Version 3
NDC: 71309-110