NIGHTTIME SLEEP-AID- diphenhydramine hcl tablet

Nighttime Sleep-aid by

Drug Labeling and Warnings

Nighttime Sleep-aid by is a Otc medication manufactured, distributed, or labeled by NORTHEAST PHARMA, Geri-Care Pharmaceutical Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each caplet)

Diphenhydramine Hydrochloride 25mg

Purpose

Nighttime Sleep-aid

Uses

• relieves occasional sleeplessness

Warnings

Do not use

in children under 12 years

with any other product containing diphenhydramine, including one used

on skin

Ask a doctor before use if you have

a breathing problem such as emphysema, asthma, or chronic bronchitis

glaucoma

trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

avoid alcoholic beverages

drowsiness will occur

do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if sleeplessness persists continuously for more than two 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.

Directions

adults and children 12 years and over: take two caplets at bedtime if needed, or as directed by a doctor

do not exceed recommended dose

Other information

• each caplet contains: calcium 85mg
• store at 20°C-25°C (68°F-77°F)
• Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

Inactive ingredients

calcium phosphate, croscarmellose sodium, magnesium stearate,

microcrystalline cellulose, silica.

Questions or comments?

1-800-540-3765

package label

INGREDIENTS AND APPEARANCE

NIGHTTIME SLEEP-AID 
diphenhydramine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80136-785
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	15mm
Flavor		Imprint Code	93XF;57344
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80136-785-96	96 in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M010	09/01/2021

Labeler - NORTHEAST PHARMA (081232935)

Registrant - Geri-Care Pharmaceutical Corp (611196254)