NIGHTTIME SLEEP AID- diphenhydramine hydrochloride capsule, liquid filled

Nighttime Sleep Aid by

Drug Labeling and Warnings

Nighttime Sleep Aid by is a Otc medication manufactured, distributed, or labeled by Spirit Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient (in each tablet)

Diphenhydramine Hydrochloride 25 mg

Purpose

Nighttime sleep-aid

Uses

for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep

Warnings

Do not use for 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 glaucoma
difficulty in urination due to enlargement of the prostate gland

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

When using this product avoid alcoholic beverages

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

take only one dose per day (24 hours)

• adults & children 12 years & over: take 2 softgels at bedtime if needed or as directed by a doctor
• children under 12 years: do not use

Other information

store at 20-25° C (68-77° F) avoid excessive heat above 40° C (104° F) and high humidity Protect from light

Inactive ingredients

FD&C Blue#1, FD&C Red#40, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

1-888-333-9792

SPL UNCLASSIFIED SECTION

Distributed By:
Spirit Pharmaceuticals, LLC
Ronkonkoma, NY 11779

Made in India

Carton

INGREDIENTS AND APPEARANCE

NIGHTTIME SLEEP AID 
diphenhydramine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68210-4195
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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	purple	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code	602
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68210-4195-2	24 in 1 BLISTER PACK; Type 0: Not a Combination Product	12/28/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M010	12/28/2021

Labeler - Spirit Pharmaceuticals LLC (179621011)