FDA.reportPublic FDA data

Allergy Relief

Manufacturer
Lil' Drug Store Products, Inc.
Effective date
2024-07-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:15:55

Label at a glance#

ProductAllergy Relief
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 due to the common cold runny nose sneezing

Dosage and administration

take every 4 to 6 hours, or as directed by a doctor do not take more than 6 doses in 24 hours adults and children 12 years and over take 1 to 2 tablets children 6 to under 12 years take 1 tablet children under 6 years do not use

Storage and handling

each tablet may contain: calcium 25 mg store at room temperature 68°-77°F (20°-25°C) protect from light and moisture

Label contents#

Full prescribing information#

Active Ingredient

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 due to 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 tranquilizers or sedatives.

When using this product

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives and 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,

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, or as directed by a doctor
  • do not take more than 6 doses in 24 hours

adults and children 12 years and over

take 1 to 2 tablets
children 6 to under 12 yearstake 1 tablet
children under 6 yearsdo not use

Other Information

STORAGE AND HANDLING SECTION

  • each tablet may contain: calcium 25 mg
  • store at room temperature 68°-77°F (20°-25°C)
  • protect from light and moisture

Inactive Ingredients

INACTIVE INGREDIENT SECTION

carnauba wax 1 , colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphate 1 , hypromellose, lactose 1 , magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 1 , titanium dioxide

1 may contain

Questions or Comments

STORAGE AND HANDLING SECTION

call toll-free 800-351-2000 (M-F 8:00 AM-4:30 PM CST)

SPL UNCLASSIFIED SECTION

* This product is not manufactured or distributed by

JOHNSON & JOHNSON CONSUMER INC,

McNeil Consumer Healthcare Division,

distributor of Benadryl® Allergy ULTRATABS®

Distributed by:

Lil’ Drug Store Products, Inc.

Cedar Rapids, IA 52404

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO THE ACTIVE INGREDIENTS IN

Benadryl® Allergy ULTRATABS®

Allergy Relief

Diphenhydramine HCl 25 mg,

Antihistamine

Relieves Symptoms of

Hay Fever, Common Cold and [tablet image here]

Other Upper Respiratory Allergies actual size

2 TABLETS IN EACH PACKET

Allergy Relief 2 tablets in each PacketAllergy Relief 2 tablets in each Packet

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN4
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29485-9285-2Allergy Relief2 in 1 POUCHTABLET, FILM COATED24
29485-9285-2Allergy Relief25 in 1 BOXTABLET, FILM COATED254
29485-9285-3Allergy Relief2 in 1 POUCHTABLET, FILM COATED24
29485-9285-3Allergy Relief30 in 1 BOXTABLET, FILM COATED304
29485-9285-4Allergy Relief50 in 1 BOXTABLET, FILM COATED504
29485-9285-4Allergy Relief2 in 1 POUCHTABLET, FILM COATED24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29485-9285ALLERGY RELIEF (DIPHENHYDRAMINE HCL 25 MG) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]4Current NDC, Legacy NDC, 6 package rows20240724_edc244d6-eb0b-d3c9-e053-2a95a90a2622.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
29485-928529485-9285-2, 29485-9285-3, 29485-9285-4

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
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
CARNAUBA WAXR12CBM0EIZIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
D&C RED NO. 272LRS185U6KIACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYSORBATE 806OZP39ZG8HIACT
MAGNESIUM STEARATE70097M6I30IACT

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefDIPHENHYDRAMINE HCL 25 MGLil' Drug Store Products, Inc.edc244d6-eb0b-d3c9-e053-2a95a90a26222024-07-22WarningsExact identifier
ndc (package): 29485-9285-4
ndc (package): 29485-9285-2
ndc (package): 29485-9285-3
ndc (product): 29485-9285
ndc11 (package): 29485928504
ndc11 (package): 29485928503
ndc11 (package): 29485928502
spl id: 1ddbfa9d-560e-50b6-e063-6294a90adfc8
spl set id: edc244d6-eb0b-d3c9-e053-2a95a90a2622

Reported adverse events (FAERS/openFDA)#

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