DIPHENHIST- diphenhydramine hcl capsule
Rugby Laboratories Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Diphenhist

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
•: itchy nose or throat
•: sneezing
•: 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

•: take every 4-6 hours
•: do not take more than 6 doses in 24 hours

adults and children 12 years and over	1 to 2 capsules
children 6 to under 12 years	1 capsule
children under 6 years	do not use

Other Information

•: store at room temperature
•: protect from moisture

Inactive Ingredients

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

Questions or Comments

Call 1-800-645-2158, 9 am – 5 pm ET, Monday - Friday

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

Rugby® Duluth, Georgia 30097

Package Label

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Diphenhydramine HCl 25 mg

NDC 0536-3594-01

Antihistamine

For the temporary relief of the symptoms of Upper Respiratory

Allergies and Hay Fever

BANDED FOR YOUR PROTECTION

100 BANDED CAPSULES

Rugby

Duluth, Georgia 30097

DIPHENHIST
diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0536-3594
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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, UNSPECIFIED (UNII: 2G86QN327L)
LACTOSE, UNSPECIFIED FORM (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	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	AP;020
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0536-3594-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/30/2006	07/29/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	05/30/2006	07/29/2018

Labeler - Rugby Laboratories Inc. (079246066)

Revised: 12/2019

Document Id: c9aaf917-e44c-4f35-8f74-bf55556403cb

Set id: 25f94311-b6e8-4f75-99d2-6419337767e1

Version: 4

Effective Time: 20191220

Rugby Laboratories Inc.