Diphenhist

Manufacturer: Rugby Laboratories Inc. | Advance Pharmaceutical Inc.
Effective date: 2012-12-07
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-02 01:44:05

Label at a glance#

ProductDiphenhist

Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE

Label structure10 sections

Indications and uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies: runny nose itchy nose or throat sneezing itchy, watery eyes

Dosage and administration

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

Contacts and useful links#

PhoneLabel contact1-800-645-2158

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each capsule)

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

runny nose
itchy nose or throat
sneezing
itchy, watery eyes

Warnings

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

store at room temperature
protect from moisture

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

$C:\Users\advance\Desktop\word docs - rugby\Diphenhydramine HCl 25mg capsule\Figure 1.png$ C:\Users\advance\Desktop\word docs - rugby\Diphenhydramine HCl 25mg capsule\Figure 1.png

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

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1049909	diphenhydrAMINE (Oral Pill)	diphenhydramine hydrochloride 25 MG Oral Capsule	SCD Active
1092447	DIPHENHIST (Oral Pill)	diphenhydramine hydrochloride 25 MG Oral Capsule [Diphenhist]	SBD Active

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0536-3594-01	EA - Each	0536-3594	1abee797-85e2-48a7-834f-832f1a3b63de	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	3
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	3
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	3
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	3
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	3
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	3
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

Diphenhist
Diphenhydramine HCl
DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE
BENZYL ALCOHOL
BUTYLPARABEN
D&C RED NO. 28
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
LACTOSE
MAGNESIUM STEARATE
METHYLPARABEN
POLYSORBATE 80
PROPYLPARABEN
SODIUM LAURYL SULFATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0536-3594	0536-3594-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB
BENZYL ALCOHOL	LKG8494WBH	IACT
BUTYLPARABEN	3QPI1U3FV8	IACT
D&C RED NO. 28	767IP0Y5NH	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
GELATIN	2G86QN327L	IACT
LACTOSE	J2B2A4N98G	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 9 · 527 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	POWDER, FOR SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, EFFERVESCENT / ORAL	96.5 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / TOPICAL	0.24 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CAPSULE, EXTENDED RELEASE / ORAL	0.22 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	POWDER, FOR SOLUTION / ORAL	0.04 mg/5ml		Exact identifier — unii candidate 37 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CONCENTRATE / INTRAVENOUS		4680 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / SUBLINGUAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, DELAYED RELEASE / ORAL	231.84 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, FILM COATED / ORAL		240 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	OINTMENT / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	OINTMENT / TOPICAL		29 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SUSPENSION / INTRAMUSCULAR		40 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	LOTION / TOPICAL		111 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CONCENTRATE / ORAL	2.5 mg/5ml		Exact identifier — unii candidate 68 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	CAPSULE, EXTENDED RELEASE / ORAL	1.23 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	SUSPENSION / ORAL		12 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION / ORAL	100 mg/5ml		Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 42 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	EMULSION / TOPICAL	0.06 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, CHEWABLE / ORAL	1.28 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, EXTENDED RELEASE / ORAL		239 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CAPSULE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / SUBCUTANEOUS		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SPRAY / NASAL	0.2 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CREAM / TOPICAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	DROPS / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	ELIXIR / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUPPOSITORY / RECTAL	72.15 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM / TOPICAL		3000 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	0.4 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	GEL / VAGINAL		100 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SUSPENSION / AURICULAR (OTIC)	0.9 %w/v		Exact identifier — unii candidate 50 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRAVITREAL	0.02 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, DELAYED RELEASE PELLETS / ORAL	0.01 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SOLUTION / INTRAMUSCULAR		500 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, COATED / ORAL		123 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRAMUSCULAR		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	CAPSULE, EXTENDED RELEASE / ORAL	0.2 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	TABLET / ORAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	DOUCHE / VAGINAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / RECTAL	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	FILM / BUCCAL		1 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, COATED / ORAL		18 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, COATED / ORAL	0.04 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE / RESPIRATORY (INHALATION)	44.4 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / VAGINAL	0.1 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / INTRAMUSCULAR		1000 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 37 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / SUBCUTANEOUS	0.3 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION/ DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	DROPS / AURICULAR (OTIC)	0.02 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SOLUTION / ORAL		126 mg	Exact identifier — unii candidate 79 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
c9aaf917-e44c-4f35-8f74-bf55556403cb			25f94311-b6e8-4f75-99d2-6419337767e1	2019-12-20	Warnings	Exact identifier spl set id: 25f94311-b6e8-4f75-99d2-6419337767e1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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