TOPCARE SLEEP AID NIGHTTIME- diphenhydramine hydrochloride tablet, film coated

topcare sleep aid by

Drug Labeling and Warnings

topcare sleep aid by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Use

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
• drowsiness may occur
• do not drive a motor vehicle or operate machinery

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.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-2222).

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 20-25°C (68-77°F). Avoid high humidity. Protect from light.
• do not use if blister unit is broken or torn

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?

1-888-423-0139

Principal Display Panel

COMPARE TO SIMPLY SLEEP® ACTIVE INGREDIENT

NIGHTTIME

Sleep Aid

DIPHENHYDRAMINE HCl 25 mg

NIGHTTIME SLEEP AID

Helps You Fall Asleep

Non Habit-Forming

OUR PHARMACISTS RECOMMEND

Does Not Contain Pain Reliever

24 CAPLETS

actual size

INGREDIENTS AND APPEARANCE

TOPCARE SLEEP AID  NIGHTTIME
diphenhydramine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-431
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
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)	Score	no score
Shape	OVAL	Size	11mm
Flavor		Imprint Code	L431
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-431-62	12 in 1 CARTON	09/11/2001
1		2 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 36800-431-67	24 in 1 CARTON	01/27/2004
2		2 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 36800-431-78	1 in 1 CARTON	09/13/2017
3		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part338	09/11/2001

Labeler - Topco Associates LLC (006935977)