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]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each softgel)

Diphenhydramine HCl 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

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 asthma, emphysema, or chronic bronchitis
• glaucoma
• difficulty in urination due to enlargement of the prostate gland
• heart disease

Ask a doctor or pharmacist before use if you are taking sedatives, tranquilizers or any other sleep aid

When using this product

• avoid alcoholic beverages and other drugs that cause drowsiness
• drowsiness will occur
• 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 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 right away. 1(800)222-1222

Directions

• take only one dose per day (24 hours) - see Overdose warning

• adults & children 12 yrs & over: One dose=TWO 25 mg softgels (50 mg) at bed time 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-400, propylene glycol, sorbitol sorbitan, titanium dioxide

Questions or comments?

1-888-333-9792

SPL UNCLASSIFIED SECTION

Distributed By:

Spirit Pharmaceuticals, LLC

Ronkonkoma, NY 11779

PRINCIPAL DISPLAY PANEL - 48 COUNT BLISTER CARTON

VALUMEDS™

Compare to the active ingredient

in ZzzQuil®*

NIGHTTIME

SLEEP-AID

DIPHENHYDRAMINE HCl 25 mg

Non Habit-Forming

Not for Treating Cold or Flu

See Warnings

48 SOFTGELS

INGREDIENTS AND APPEARANCE

NIGHTTIME SLEEP AID 
diphenhydramine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68210-2010
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 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68210-2010-0	48 in 1 CARTON	04/16/2018
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 68210-2010-1	1 in 1 CARTON	04/16/2018
2		12 in 1 BLISTER PACK; 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	04/16/2018

Labeler - SPIRIT PHARMACEUTICALS LLC (179621011)

Establishment
Name	Address	ID/FEI	Business Operations
MEDGEL PRIVATE LIMITED		677385498	manufacture(68210-2010)