DIPHENHYDRAMINE- diphenhydramine hydrochloride capsule

DIPHENHYDRAMINE by

Drug Labeling and Warnings

DIPHENHYDRAMINE by is a Otc medication manufactured, distributed, or labeled by PURINEPHARMA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient (each banded capsule contains)

Diphenhydramine HCL 50 mg

PURPOSE

Purpose

Antihistaminne

INDICATIONS & USAGE

Uses

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  
  • runny nose
  • sneezing
  • itchy, Watery eyes
  • itching of the nose or throat

WARNINGS

Ask a doctor before use if you have

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

Do not use to make a child sleepy

Do not use with any other product containing diphenhydramine, even one used on skin

WHEN USING

When using this product

• marked drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children, In case of overdose, get medical help or contact a Poison control center right away.

DOSAGE & ADMINISTRATION

Directions:

• Take every 4 to 6 hours.
• Do not take more than 6 doses in any 24-hour period.

• Adults and Children 12 years of age and over: 1 to 2 capsules
• Children 6 to under 12 years of age: 1 capsule
• Children under 6 years of age: Do not use

STORAGE AND HANDLING

Other information

• Store between 15-30 degree Celsius (59-86 degree Fahrenheit)
• Protect from moisture

INACTIVE INGREDIENT

D&C red 28, gelatin, lactose monohydrate, magnesium stearate, maize starch, polysorbate tween 80, silica gel.

HOW SUPPLIED

Pack Size: 50 Capsules in a Bottle
Batch No.:
Mfg. Date:
Exp. Date:

OTHER SAFETY INFORMATION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING OR IF RED BAND AROUND CAPSULE IS BROKEN OR MISSING.

PRINCIPAL DISPLAY PANEL

NDC: 58599-004-90
NDC: 58599-004-25
NDC: 58599-004-29
NDC: 58599-004-35

Manufactured By: PURINEPHARMA LLC
5 County Route 42
Massena, NY – 13662
www.purinepharma.com

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE 
diphenhydramine hydrochloride capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58599-004
Route of Administration	ORAL, Type 0: Not a Combination Product

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
D&C RED NO. 28 (UNII: 767IP0Y5NH)
GELATIN (UNII: 2G86QN327L)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Product Characteristics
Color	PINK (PINK CAP and PINK BODY)	Score	2 pieces
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	DH;50
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58599-004-90	50000 in 1 BOX
2	NDC: 58599-004-25	1 in 1 CARTON
2		50 in 1 BOTTLE
3	NDC: 58599-004-29	1 in 1 CARTON
3		100 in 1 BOTTLE
4	NDC: 58599-004-35	1 in 1 CARTON
4		1000 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/31/2014

Labeler - PURINEPHARMA LLC (019950491)

Registrant - PURINEPHARMA LLC (019950491)

Establishment
Name	Address	ID/FEI	Business Operations
PURINEPHARMA LLC		019950491	manufacture(58599-004)