OTC Medication Information: Sleep-EZ Nighttime Sleep Aid
SLEEP-EZ NIGHTTIME SLEEP AID- diphenhydramine hydrochloride tablet, coated
Safrel Pharmaceuticals, LLC.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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
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Labeler — Safrel Pharmaceuticals, LLC. (080566287) |
Revised: 05/2021 Safrel Pharmaceuticals, LLC.
Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.
https://otclabels.com/lib/otc/otc-meds/sleep-ez-nighttime-sleep-aid/