Smart sense sleep aid tablet

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

for relief of occasional sleeplessness

Warnings

Do not use

  • in children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin

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

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

avoid alcoholic drinks

Stop use and ask a doctor if

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

adults and children 12

years and over

take 2 caplets at bedtime if needed or as directed by a doctor

children under 12 years

do not use

Other information

  • each caplet contains: calcium 15 mg
  • store at 20-25C (68-77F)

Inactive ingredients

carnauba wax, crospovidone, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

1-800-719-9260

Ingredients and appearance - Product information

Smart sense sleep aid tablet- Diphenhydramine hydrochloride

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 49738-476
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Diphenhydramine hydrochloride ( UNII: TC2D6JAD40)( Diphenhydramine - UNII: 8GTS82S83M ) 25 mgin 1

Inactive Ingredients

Ingredient Name Code
Carnauba wax ( UNII: R12CBM0EIZ)
Crospovidone (15 mpa.s at 5%) ( UNII: 68401960MK)
Dibasic calcium phosphate dihydrate ( UNII: O7TSZ97GEP)
Hypromelloses ( UNII: 3NXW29V3WO)
Magnesium stearate ( UNII: 70097M6I30)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Polyethylene glycol ( UNII: 3WJQ0SDW1A)
Polysorbate 80 ( UNII: 6OZP39ZG8H)
Stearic acid ( UNII: 4ELV7Z65AP)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color BLUE (Light Blue) Size 11 mm
Shape CAPSULE Score 1
Imprint Code L431

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part338 USA

Labeler - Kmart Corporation( 008965873)

Principal display panel

Compare to active ingredient of Simply Sleep® Nighttime Sleep Aid Caplets

NIGHTTIME SLEEP-AID

Sleep-Aid

Diphenhydramine HCl 25 mg

Does not contain Pain Reliever

For a Restful Nights Sleep

Safe, Non-Habit Forming

100 CAPLETS