DIPHENHYDRAMINE HYDROCHLORIDE capsule, liquid filled

DIPHENHYDRAMINE HYDROCHLORIDE by

Drug Labeling and Warnings

DIPHENHYDRAMINE HYDROCHLORIDE by is a Otc medication manufactured, distributed, or labeled by Humanwell PuraCap Pharmaceutical (Wuhan), Ltd., Epic Pharma, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each capsule)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Uses

• for the relief of occasional sleeplessness

Warnings

• do not give to children under 12 years of age
• do not use 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
• 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 drinks.

Stop use and ask a doctor if

• sleeplessness persist 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.

Directions

• adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor.

Other information

• store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
• do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special and white edible ink.

Manufactured by:
Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.
Wuhan, Hubei
430206, China

PRINCIPAL DISPLAY PANEL - Shipping Label

DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES, 50 mg

Quantity : 12000 Capsules
NDC. No : 53345-005-01

IMPORTANT:

Inspect immediate upon receipt.
This is a bulk shipment intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.

CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"

PRINCIPAL DISPLAY PANEL - Shipping Label

DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES, 50 mg

Quantity : 80 Bottles
NDC. No : 53345-005-02

IMPORTANT:

Inspect immediate upon receipt.
This is a bulk shipment intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.

CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53345-005
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, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	blue	Score	no score
Shape	CAPSULE (oval)	Size	13mm
Flavor		Imprint Code	PC5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53345-005-01	1 in 1 BOX	04/15/2013
1		12000 in 1 BAG; Type 0: Not a Combination Product
2	NDC: 53345-005-02	80 in 1 BOX	04/15/2013
2		32 in 1 BOTTLE, PLASTIC; 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	04/15/2013

Labeler - Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. (421293287)

Registrant - Epic Pharma, LLC (827915443)

Establishment
Name	Address	ID/FEI	Business Operations
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.		421293287	manufacture(53345-005) , analysis(53345-005)