FDA.reportPublic FDA data

Allergy, Lil Drug Store

Manufacturer
Lil' Drug Store Products, Inc.
Effective date
2023-12-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:04:27

Label at a glance#

ProductAllergy, Circle K
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

OTC - PURPOSE SECTION

Purpose

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

OTC - WHEN USING SECTION

When using this product

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

SPL UNCLASSIFIED SECTION

  • each tablet contains: calcium 30 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • protect from moisture
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

[caduceus] *Compare to the Active Ingredient
in Benadryl ® Allergy ULTRATAB ® Tablets

Allergy
Diphenhydramine HCI 25 mg
Antihistamine

Relieves
• Runny Nose • Sneezing [tablet image]

• Itchy, Watery Eyes ACTUAL SIZE
• Itchy Nose or Throat

36
Tablets [Lil' Drug Store logo]

PDPPDP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RELIEVES SYMPTOMS OF HAY FEVER & OTHER ALLERGIES
Compare to the active ingredient in
Benadryl ® Allergy ULTRATAB® Tablets*

CIRCLE K

multi-symptom
allergy

Diphenhydramine HCI 25 mg,
Antihistamine

[tablet image]

actual size

36 tablets

PDPPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN3
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD3

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
66715-5154-8Allergy, Circle K3 in 1 CARTONTABLET, COATED33
66715-5154-8Allergy, Circle K12 in 1 BLISTER PACKTABLET, COATED123
66715-6914-8Allergy, Lil Drug Store3 in 1 CARTONTABLET, COATED33
66715-6914-8Allergy, Lil Drug Store12 in 1 BLISTER PACKTABLET, COATED123

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-5154ALLERGY, CIRCLE K (DIPHENHYDRAMINE HCL 25MG TABLET) TABLET, COATED ALLERGY, LIL DRUG STORE (DIPHENHYDRAMINE HCL 25MG TABLET) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]3Current NDC, Legacy NDC, 2 package rows20231215_d1f370ac-e7f4-baf7-e053-2995a90a1e50.zip
66715-6914ALLERGY, CIRCLE K (DIPHENHYDRAMINE HCL 25MG TABLET) TABLET, COATED ALLERGY, LIL DRUG STORE (DIPHENHYDRAMINE HCL 25MG TABLET) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]3Current NDC, Legacy NDC, 2 package rows20231215_d1f370ac-e7f4-baf7-e053-2995a90a1e50.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
66715-515466715-5154-8
66715-691466715-6914-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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, Circle KDIPHENHYDRAMINE HCL 25MG TABLETLil' Drug Store Products, Inc.d1f370ac-e7f4-baf7-e053-2995a90a1e502023-12-14WarningsExact identifier
ndc (package): 66715-5154-8
ndc (package): 66715-6914-8
ndc (product): 66715-6914
ndc (product): 66715-5154
ndc11 (package): 66715515408
ndc11 (package): 66715691408
spl id: 0c7b8b84-3a6a-7cb1-e063-6294a90a42a4
spl set id: d1f370ac-e7f4-baf7-e053-2995a90a1e50

Reported adverse events (FAERS/openFDA)#

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