DIPHENHYDRAMINE HCL capsule, liquid filled

Diphenhydramine HCl by

Drug Labeling and Warnings

Diphenhydramine HCl by is a Otc medication manufactured, distributed, or labeled by AiPing Pharmaceutical, Inc., Anshi Pharmaceutical (Zhongshan) Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each softgel)

Diphenhydramine HCI 50 mg

Purpose

Nighttime sleep-aid

Use

• for relief of occasional sleeplessness

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
• 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.

Inactive ingredients

FD&C blue #1, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution and white edible ink

PRINCIPAL DISPLAY PANEL

Diphenhydramine Hydrochloride Softgels, USP 50 mg

Quantity : 13000 Softgels
NDC. No : 11788-018-00

WARNING:

KEEP OUT OF THE REACH OF CHILDREN. THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY. CONTENTS SHOULD BE REPACKAGED IMMEDIATELY AND LABELED IN STRICK CONFORMANCE WITH THE FOOD DRUG & COSMETIC ACT AND REGULATIONS THEREUNDER.

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HCL 
diphenhydramine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11788-018
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	blue	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	AP018
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11788-018-00	1 in 1 BOX	01/31/2015
1		13000 in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/31/2015

Labeler - AiPing Pharmaceutical, Inc. (079674526)

Registrant - AiPing Pharmaceutical, Inc. (079674526)

Establishment
Name	Address	ID/FEI	Business Operations
Anshi Pharmaceutical (Zhongshan) Inc.		528101821	manufacture(11788-018)