Allergy Relief

Manufacturer: Strategic Sourcing Services LLC
Effective date: 2022-11-08
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: legacy-cache
Hydrated at: 2026-08-01 21:49:04

Label at a glance#

ProductAllergy Relief Antihistamine

Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE

Label structure10 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily relieves these symptoms of the common cold: runny nose sneezing

Dosage and administration

take every 4 to 6 hours do not more than 6 doses in 24 hours adults and children 12 years of age and over 1 to 2 tablets children 6 to under 12 years of age 1 tablet children under 6 years of age do not use this product in children under 6 children under 4 years of age do not use

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-877-753-3935

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

runny nose
sneezing
itchy, watery eyes
itching of the nose or throat

temporarily relieves these symptoms of the common cold:

runny nose
sneezing

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

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

adults and children 12 years of age and over	1 to 2 tablets
children 6 to under 12 years of age	1 tablet
children under 6 years of age	do not use this product in children under 6
children under 4 years of age	do not use

Other information

OTHER SAFETY INFORMATION

each tablet contains: calcium 25mg/ tablet
store at room temperature 15°-30°C (59°-86°F)
protect from light and moisture
do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Aluminum Lake, dibasic calcium phosphate dihydrate, hypromellose, *lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80, *polyvinyl alcohol, *purified water, *talc, and titanium dioxide

* Contains one or more of these ingredients

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-877-753-3935 Monday- Friday 9AM- 5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Allergy Relief

Antihistamine

For the temporary relief of:

sneezing, itchy & watery eyes, runny nose & itchy throat

Diphenhydramine HCl 25 mg

Compare to Benadryl® Allergy ultratab® Active Ingredient*

*This product is not manufactured or distributed by McNeil Consumer Healthcare, Division of McNeil-PPC, Inc., owner of the registered trademark Benadryl® Allergy Ultratab®

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Diphenhydramine HCl 25 mg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49348-983-04	EA - Each	49348-983	bc6d9be8-95be-4f54-b016-d51076c84ddf	1	2015-10-02
49348-983-10	EA - Each	49348-983	603125af-e9d2-467a-9075-33e66ed8c60b	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	1
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	1
EGG PHOSPHOLIPIDS	INACTIVE INGREDIENT	1Z74184RGV	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

Allergy Relief Antihistamine
Diphenhydramine HCl
DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE
CARNAUBA WAX
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
D&C RED NO. 27
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
HYPROMELLOSES
EGG PHOSPHOLIPIDS
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
POLYVINYL ALCOHOL, UNSPECIFIED
WATER
TALC
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
49348-983	49348-983-10, 49348-983-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB
CARNAUBA WAX	R12CBM0EIZ	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
D&C RED NO. 27	2LRS185U6K	IACT
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	O7TSZ97GEP	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
EGG PHOSPHOLIPIDS	1Z74184RGV	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
POLYVINYL ALCOHOL, UNSPECIFIED	532B59J990	IACT
WATER	059QF0KO0R	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	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 7 · 401 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	GRANULE / ORAL		45 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	GUM, CHEWING / BUCCAL		10 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	PASTE, DENTIFRICE / DENTAL	0.4 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION / ORAL		70200 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, LIQUID FILLED / ORAL		12 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING / ORAL		1800 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, DELAYED RELEASE / ORAL		420 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE / ORAL		1488 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
EGG PHOSPHOLIPIDS	EGG PHOSPHOLIPIDS	1Z74184RGV	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	48.75 mg		Exact identifier — unii candidate 5 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE, DELAYED RELEASE / ORAL		105 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRAVENOUS		4680 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, COATED / ORAL		184 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, DELAYED RELEASE / ORAL		26 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
POLYVINYL ALCOHOL	POLYVINYL ALCOHOL	532B59J990	SOLUTION / OPHTHALMIC		6 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
D&C RED NO. 27	D&C RED NO. 27	2LRS185U6K	TABLET, EXTENDED RELEASE / ORAL	1.43 mg		Exact identifier — unii candidate 4 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS		4739 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	GEL / TOPICAL		12 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYVINYL ALCOHOL	POLYVINYL ALCOHOL	532B59J990	SUSPENSION / OPHTHALMIC	1.4 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE / ORAL		257 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, CHEWABLE / ORAL	11.8 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE / ORAL		254 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
POLYVINYL ALCOHOL	POLYVINYL ALCOHOL	532B59J990	TABLET, ORALLY DISINTEGRATING / ORAL		2 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		60 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE, COATED PELLETS / ORAL	3.32 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FOR SUSPENSION / ORAL		24 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, LIQUID FILLED / ORAL		1122 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL		992 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRALESIONAL		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SUPPOSITORY / RECTAL	0.25 mg/mg		Exact identifier — unii candidate 36 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	PELLET / ORAL		162 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRAMUSCULAR	4 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRASYNOVIAL	0.2 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRAMUSCULAR		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SPRAY, METERED / NASAL	0.1 mg/1ml		Exact identifier — unii candidate 78 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	TABLET, COATED / ORAL	488.7 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
EGG PHOSPHOLIPIDS	EGG PHOSPHOLIPIDS	1Z74184RGV	EMULSION / INTRAVENOUS	1.2 %w/v		Exact identifier — unii candidate 5 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, EXTENDED RELEASE / ORAL		90 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / VAGINAL	8 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	INSERT / VAGINAL	54.21 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / RESPIRATORY (INHALATION)	0.13 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRA-ARTICULAR		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYVINYL ALCOHOL	POLYVINYL ALCOHOL	532B59J990	TABLET, COATED / ORAL	0.7 mg		Exact identifier — unii candidate 17 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET / SUBLINGUAL	32.4 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE PARTICLES / ORAL		170 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION, EXTENDED RELEASE / ORAL		70 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, ORALLY DISINTEGRATING / ORAL		41 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
POLYVINYL ALCOHOL	POLYVINYL ALCOHOL	532B59J990	CAPSULE / ORAL	1.67 mg		Exact identifier — unii candidate 17 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE PELLETS / ORAL		24 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	IMPLANT / SUBCUTANEOUS	0.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	SUSPENSION, EXTENDED RELEASE / ORAL		1120 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, EXTENDED RELEASE / ORAL		450 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / SUBCUTANEOUS	0.3 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	EMULSION / TOPICAL		34050 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUPPOSITORY / VAGINAL	28 mg		Exact identifier — unii candidate 78 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
4082d74b-ed71-4e52-832a-5a8ae3ea741e			dbda69b4-18b6-4d25-9e63-44b83b920b83	2022-12-12	Warnings	Exact identifier spl set id: dbda69b4-18b6-4d25-9e63-44b83b920b83

Reported adverse events (FAERS/openFDA)#

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

Allergy Relief

Label at a glance#

Indications and uses

Dosage and administration

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

Purpose

Uses

Warnings

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

If pregnant of breast-feeding,

Keep out of reach of children.

Directions

Other information

Inactive ingredients

Questions or comments?

Principal Display Panel

Product Label

Related RxNorm Concepts#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

NDC Codes#

Ingredients#

Source Document#

Inactive ingredient matches#

openFDA label cross-check#

Reported adverse events (FAERS/openFDA)#