DIPHENHIST- diphenhydramine hcl capsule

Diphenhist by

Drug Labeling and Warnings

Diphenhist by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each banded capsule)

Diphenhydramine HCl 25 mg

PURPOSE

Purpose

Antihistamine

Uses

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

• runny nose 
• sneezing 
• itchy, watery eyes
• itching of the nose or throat
• temporarily relieves these symptoms due to the common cold: 
• runny nose 
• sneezing

Warnings

Do not use

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

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if

you are taking sedatives or tranquilizers

When using this product

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

If pregnant of 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: 1-800-222-1222

In case of overdose, get medical help or contact a Poison Control Center right away: 1-800-222-1222

Directions

• take every 4 to 6 hours 
• do not take more than 6 doses in 24 hours

• 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 this product in children under 6 years of age

Other information

• store at controlled room temperature 15°-30°C (59°-86°F) in a dry place
• protect from moisture
• contains lactose

Inactive ingredients

D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose and starch.

Questions or comments?

1-800-645-2158

SPL UNCLASSIFIED SECTION

DO NOT USE IF EITHER CAPSULE BAND OR IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by: Rugby Laboratories

17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152

www.rugbylaboratories.com

PRINCIPAL DISPLAY PANEL

Rugby

NDC: 0536-1010-01

Diphenhist

Diphenhydramine HCl USP, 25 mg

Antihistamine

For the temporary relief of the Symptoms of Upper Respiratory Allergies & Hay Fever

100 Banded Capsules

INGREDIENTS AND APPEARANCE

DIPHENHIST 
diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1010
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
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)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	pink (Half pink and half clear with white powder inside)	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	CPC;835
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1010-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/17/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/17/2014

Labeler - Rugby Laboratories (079246066)