FDA Label for Sleep-ez Nighttime Sleep Aid
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH CAPLET)
- PURPOSE
- USES
- WARNINGS
- 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
- IF PREGNANT OR BREAST-FEEDING
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Sleep-ez Nighttime Sleep Aid Product Label
The following document was submitted to the FDA by the labeler of this product Safrel Pharmaceuticals, Llc.. 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.
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
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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
* Please review the disclaimer below.