DIPHENHYDRAMINE HCL capsule

Diphenhydramine HCl by

Drug Labeling and Warnings

Diphenhydramine HCl by is a Otc medication manufactured, distributed, or labeled by PD-Rx Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient(in each banded capsule)

Diphenhydramine HCL 25 mg

Purpose

Antihistamine

Uses:

• Temporarily relieves these symptoms due to common cold, hay fever, or other upper respiratory allergies:

-Sneezing

-watery eyes

-Runny nose

-Itchy, watery eyes

Warnings:

Do not use

• To make child sleepy
  
  with any other product containing diphenhydramine, even one used on skin.
  

Ask a doctor or pharmacist before use

If you have

• Trouble urinating due to an enlarged prostate gland
• A breathing problem such as emphysema or chronic bronchitis
• Glaucoma

Ask a doctor or pharmacist before use of 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 accidental overdose, get medical help or contact a Poison Control Center immediately. (800) 222-1222.

Directions:

• Take every 4-6 hours, or as directed by a doctor
• Do not exceed 6 times in 24 hours.

• Adults and children 12 years and above: (1 to 2 capsules)
• Children 6 to under 12 years: (1 capsule)
• Children under 6 years: ask a doctor

Other information:

• Tamper Evident: Do not use if safety seal is broken or missing from bottle.
  
• Store at controlled room temperature 20°-25°C (68°-77°F)
• Protect from excessive moisture

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

Questions? Adverse drug event call: (866)562-2756

16. HOW SUPPLIED/STORAGE AND HANDLING

Pink and white capsule with red band, imprinted with PH014, supplied as:

Bottles of 30 (NDC: 55289-479-30).

Storage

Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HCL 
diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55289-479(NDC:16103-348)
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 (UNII: 2G86QN327L)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Product Characteristics
Color	pink (PINK (clear) , WHITE (clear) , RED (band))	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: 55289-479-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/11/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/11/2006

Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)

Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)

Establishment
Name	Address	ID/FEI	Business Operations
PD-Rx Pharmaceuticals, Inc.		156893695	repack(55289-479)