DIPHENHYDRAMINE HCL capsule

Diphenhydramine HCL by

Drug Labeling and Warnings

Diphenhydramine HCL by is a Otc medication manufactured, distributed, or labeled by RPK Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient(in each capsule)

Diphenhydramine HCL 25 mg

Purpose

Antihistamine

Uses:

• Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies.
• Sneezing.
• Nasal congestion.
• Runny nose.
• Itchy, watery eyes.
  

Warnings:

Do not use

• With any other product containing Diphenhydramine HCL, including one applied topically.
  

Ask a doctor or pharmacist before use

If you haveTrouble urinating due to enlarged prostate glandA breathing problem such as emphysema or chronic bronchitisGlaucomaIf you are taking sedatives or tranquilizers

When using this product

• Avoid alcoholic drinks.
• Marked drowsiness may occur.
• Excitability may occur, especially in children.
• Alcohol, sedatives and tranquilizers may increase drowsiness.
• Be careful when driving a motor vehicle or operating machinery.

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:

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

• Adults and children 12 years or over: 1 to 2 capsule
• Children 6 to under 12 years: 1 capsule
• Children under 6 years: ask a doctor

Other information:

• Store at room temperature 15-30  degrees C (59-86 degrees F)
• Protect from excessive moisture

Inactive ingredients: Black Iron Oxide, D & C Red #28, FD & C Blue #1, FD & C Red #40, Gelatin, Lactose Monohydrate, Magnesium Stearate, Silicon Dioxide, Sodium Lauryl Sulfate

HOW SUPPLIED

Product: 53002-3140

NDC: 53002-3140-1 10 CAPSULE in a BOTTLE

NDC: 53002-3140-2 15 CAPSULE in a BOTTLE

NDC: 53002-3140-3 20 CAPSULE in a BOTTLE

NDC: 53002-3140-4 30 CAPSULE in a BOTTLE

Diphenhydramine HCl 25mg Capsules, USP

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HCL 
diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53002-3140(NDC:66424-020)
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Product Characteristics
Color	pink	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	PH014
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53002-3140-1	10 in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2018
2	NDC: 53002-3140-2	15 in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2018
3	NDC: 53002-3140-3	20 in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2018
4	NDC: 53002-3140-4	30 in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/27/2010

Labeler - RPK Pharmaceuticals, Inc. (147096275)

Establishment
Name	Address	ID/FEI	Business Operations
RPK Pharmaceuticals, Inc.		147096275	RELABEL(53002-3140) , REPACK(53002-3140)