Diphenhydramine Hydrochloride 25 MG Oral Capsule

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Drug Information

Imprint:	PC11
Shape:	C48336
Color:	C48327
Ingredients:	Diphenhydramine
Size:	15.00
Score:	1
Rxtty:	SCD
Author:	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
Inactive Ingredients:	FD&C BLUE NO. 1 / FD&C RED NO. 40 / GELATIN / GLYCERIN / POLYETHYLENE GLYCOLS / WATER / SORBITOL>

SPL UNCLASSIFIED SECTION

Drug Facts
Active ingredient (in each capsule)

Diphenhydramine HClÂ 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
- with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
- do not use with NyQuil
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 aretaking sedatives or 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 ifsleeplessness 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.

Directions

adults & children 12 yrs & over	Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â One dose = TWO 25 mg softgels (50 mg) Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â at bedtime if needed or as directed by a doctor

Other information
- store at room temperature 15Â°-30Â°C (59Â°-86Â°F)
- avoid excessive heat above 40Â°C (104Â°F) and high humidity
- protect from light
Inactive ingredients

FD&C blue #1, FD&C red #40, 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, 25 mg

Quantity : 20000 Capsules
NDC. No : 53345-002-02

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 HYDROCHLORIDEÂ
diphenhydramine hydrochloride capsule, liquid filled

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25Â mg

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)	Â
FD&C RED NO. 40 (UNII: WZB9127XOA)	Â
GELATIN (UNII: 2G86QN327L)	Â
GLYCERIN (UNII: PDC6A3C0OX)	Â
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)	Â
WATER (UNII: 059QF0KO0R)	Â
SORBITOL (UNII: 506T60A25R)	Â

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:53345-002-02	1 in 1 BOX	04/15/2013
1		20000 in 1 BAG; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M010	04/15/2013

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

Name	Address	ID/FEI	Business Operations
Establishment
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.		421293287	manufacture(53345-002)