NIGHTIME SLEEP AID- diphenhydramine capsule, liquid filled

Nightime Sleep Aid by

Drug Labeling and Warnings

Nightime Sleep Aid by is a Otc medication manufactured, distributed, or labeled by Agile Pharmachem. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

(in each softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep aid

Uses

• For relief of occasional sleeplessness.

Directions

• adults and children 12 years and over : one softgel (50 mg) at bed time if needed or as directed by a doctor.
• children under 12 years:do not use

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

• glaucoma
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis

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

  When using this product

• avoid alcoholic drinks

  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)

Other Information

• save carton for full directions and warnings

Inactive Ingredients

Blue 1, gelatin, glycerin, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, sorbitol, titanium dioxide and water.

Questions or Comments

Call 1-855-314-1850

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DIPHENHYDRAMINE HYDROCHLORIDE SOFTGEL CAPSULE, USP 50 MG

NDC: 58805-006-00  Softgel Liquid filled

INGREDIENTS AND APPEARANCE

NIGHTIME SLEEP AID 
diphenhydramine capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58805-006
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
SORBITOL (UNII: 506T60A25R)
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BLUE	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	206
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58805-006-00	750 in 1 BOX
1		1 in 1 BAG
2	NDC: 58805-006-01	750 in 1 BOX
2		30 in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/31/2014

Labeler - Agile Pharmachem (650687853)

Registrant - Agile Pharmachem (650687853)