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

Sleep Aid
(click image for full-size original)
SLEEP-EZ NIGHTTIME SLEEP AID
diphenhydramine hcl 25 mg tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71309-110
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
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
Product Characteristics
Color blue Score no score
Shape CAPSULE Size 11mm
Flavor Imprint Code EC
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71309-110-25 25 POUCH in 1 BOX contains a POUCH
1 2 TABLET, COATED in 1 POUCH This package is contained within the BOX (71309-110-25)
2 NDC:71309-110-50 50 POUCH in 1 BOX contains a POUCH
2 2 TABLET, COATED in 1 POUCH This package is contained within the BOX (71309-110-50)
3 NDC:71309-110-02 2 POUCH in 1 POUCH contains a POUCH
3 2 TABLET, COATED in 1 POUCH This package is contained within the POUCH (71309-110-02)
4 NDC:71309-110-10 100 BOTTLE in 1 BOTTLE contains a BOTTLE (71309-110-01)
4 NDC:71309-110-01 1000 BOTTLE in 1 BOTTLE This package is contained within the BOTTLE (71309-110-10) and contains a BOTTLE (71309-110-05)
4 NDC:71309-110-05 500 BOTTLE in 1 BOTTLE This package is contained within the BOTTLE (71309-110-01) and contains a BOTTLE (71309-110-30)
4 NDC:71309-110-30 30 CARTON in 1 BOTTLE This package is contained within the BOTTLE (71309-110-05) and contains a CARTON
4 1 TABLET, COATED in 1 CARTON This package is contained within a BOTTLE (71309-110-30) and a BOTTLE (71309-110-05) and a BOTTLE (71309-110-01) and a BOTTLE (71309-110-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 06/01/2017
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.

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.

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