Sleep-ez Nighttime Sleep Aid

Sleep-ez Nighttime Sleep Aid
SPL v3
SPL
SPL Set ID 87537ba2-f4d7-8ea3-e053-2a95a90acc38
Route
ORAL
Published
Effective Date 2017-06-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Cellulose, Microcrystalline Titanium Dioxide Polyvinyl Alcohol Polyethylene Glycol, Unspecified Talc Fd&c Blue No. 1 Fd&c Blue No. 2 Silicon Dioxide Croscarmellose Sodium Anhydrous Dibasic Calcium Phosphate Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Imprint: EC Shape: capsule Color: blue Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-06-01

Description

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid


Medication Information

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 25 mg

Uses

provides relief of occasional sleeplessness

Warnings

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
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
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

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.

Active Ingredient (in Each Caplet)

Diphenhydramine HCl 25 mg

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


Structured Label Content

Uses

provides relief of occasional sleeplessness

Purpose

Nighttime sleep-aid

Warnings

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
Do Not Use (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
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? (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

When Using This Product (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 (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 (If pregnant or breast-feeding)

ask a health professional before use.

Keep Out of Reach of Children. (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.

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)

taking sedative or tranquilizers or any other sleep-aid


Advanced Ingredient Data


Raw Label Data

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