DIPHENHYDRAMINE HYDROCHLORIDE capsule

Diphenhydramine Hydrochloride by

Drug Labeling and Warnings

Diphenhydramine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Richmond Pharmaceuticals Inc., Advance Pharmaceutical Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

(in each capsule)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

• runny nose
• sneezing
• itchy nose or throat
• itchy, watery eyes

Warnings

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

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

• you may get very drowsy
• avoid alcoholic drinks
• alcohol, sedatives & tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

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 and over: take 1 to 2 capsules every 4 to 6 hours; not more than 6 doses in 24 hours
• children under 12 years: ask a doctor

Other information

• store at 15-30°C(59-86°F)
• protect from moisture

Inactive ingredients

benzyl alcohol, butylparaben, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium lauryl sulfate

Questions or comments? 

call 804-270-4498, 8:30 am - 4:30 pm ET, Monday – Friday

TAMPER EVIDENT: DO NOT USE IF BLISTER PACK IS TORN OR DAMAGED

*Richmond Pharmaceuticals, Inc. is not affiliated with the owner of the trademark BENADRYL® Allergy.

Distributed by: Richmond Pharmaceuticals Inc., Richmond, VA 23233 Made in USA

RI1010

Principle Display Panel

Richmond Pharmaceuticals, Inc.

*Compare to active ingredient in BENADRYL® Allergy

Diphenhydramine HCI Capsules, USP

25 mg
50 mg

ANTIHISTAMINE

100 CAPSULES (10 x 10)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54738-115
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
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
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 (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Product Characteristics
Color	pink (pink, natural)	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	AP;20
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54738-115-13	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/15/2000

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/15/2000

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54738-116
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
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
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 (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Product Characteristics
Color	pink (pink, pink)	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	AP;21
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54738-116-13	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/15/2000

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/15/2000

Labeler - Richmond Pharmaceuticals Inc. (043569607)

Registrant - Advance Pharmaceutical Inc. (078301063)

Establishment
Name	Address	ID/FEI	Business Operations
Advance Pharmaceutical Inc.		078301063	manufacture(54738-115, 54738-116)