FDA.reportPublic FDA data

Lil Drug Store Products Allergy

Manufacturer
Lil Drug Store Products, Inc
Effective date
2020-04-23
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 23:34:13

Label at a glance#

ProductLil Drug Store Products Allergy Antihistamine
Active ingredientDiphenhydramine Hydrochloride
Label structure12 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 contains: calcium 25 mg store at 68°-77°F (20°-25°C) protect from light and moisture

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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 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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are 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 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 (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 overtake 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 contains: calcium 25 mg
  • store at 68°-77°F (20°-25°C)
  • protect from light and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, lecithin1, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, polyvinyl alcohol1, purified water1, talc1, titanium dioxide

1 contains one or more of these ingredients

Questions or comments ?

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL - 25 mg Tablet Blister Pack Carton - NDC 66715-6854

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QUALITY
⋆ GUARANTEED ⋆

Compare to the Active Ingredient
in Benadryl® Allergy**

Allergy

Diphenhydramine HCl 25 mg
Antihistamine

Relieves
• Runny Nose • Sneezing
• Itchy, Watery Eyes
• Itchy Nose or Throat

ACTUAL SIZE

24
Tablets

Lil'
Drug Store®

PRINCIPAL DISPLAY PANEL - 25 mg Tablet Blister Pack Carton - NDC 66715-6854
PRINCIPAL DISPLAY PANEL - 25 mg Tablet Blister Pack Carton - NDC 66715-6854

PRINCIPAL DISPLAY PANEL - 25 mg Tablet Blister Pack Carton - NDC 66715-6754

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QUALITY
⋆ GUARANTEED ⋆

Compare to the Active Ingredient
in Benadryl® Allergy**

Allergy

Diphenhydramine HCl 25 mg
Antihistamine

Relieves
• Runny Nose • Sneezing
• Itchy, Watery Eyes
• Itchy Nose or Throat

ACTUAL SIZE

24
Tablets

Lil'
Drug Store®

PRINCIPAL DISPLAY PANEL - 25 mg Tablet Blister Pack Carton - NDC 66715-6754
PRINCIPAL DISPLAY PANEL - 25 mg Tablet Blister Pack Carton - NDC 66715-6754

PRINCIPAL DISPLAY PANEL - 25 mg Tablet Blister Pack Carton - NDC 66715-6654

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QUALITY
⋆ GUARANTEED ⋆

Compare to the Active Ingredient
in Benadryl® Allergy**

Allergy

Diphenhydramine HCl 25 mg
Antihistamine

Relieves
• Runny Nose • Sneezing
• Itchy, Watery Eyes
• Itchy Nose or Throat

ACTUAL SIZE

24
Tablets

Lil'
Drug Store®

PRINCIPAL DISPLAY PANEL - 25 mg Tablet Blister Pack Carton - NDC 66715-6654
PRINCIPAL DISPLAY PANEL - 25 mg Tablet Blister Pack Carton - NDC 66715-6654

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
66715-685466715-6854-0
66715-675466715-6754-0
66715-665466715-6654-0

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 42 matching rows.

Name, UNII, Kind table
NameUNIIKind
Diphenhydramine HydrochlorideTC2D6JAD40ACTIB
Carnauba WaxR12CBM0EIZIACT
Silicon DioxideETJ7Z6XBU4IACT
Croscarmellose SodiumM28OL1HH48IACT
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
Dibasic Calcium Phosphate DihydrateO7TSZ97GEPIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
Egg Phospholipids1Z74184RGVIACT
Magnesium Stearate70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
Polyethylene Glycol 400B697894SGQIACT
Polysorbate 806OZP39ZG8HIACT
Titanium Dioxide15FIX9V2JPIACT
Water059QF0KO0RIACT
Diphenhydramine HydrochlorideTC2D6JAD40ACTIB
Carnauba WaxR12CBM0EIZIACT
Silicon DioxideETJ7Z6XBU4IACT
Croscarmellose SodiumM28OL1HH48IACT
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
Dibasic Calcium Phosphate DihydrateO7TSZ97GEPIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
Egg Phospholipids1Z74184RGVIACT
Magnesium Stearate70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
Polyethylene Glycol 400B697894SGQIACT
Polysorbate 806OZP39ZG8HIACT
Titanium Dioxide15FIX9V2JPIACT
Water059QF0KO0RIACT
Diphenhydramine HydrochlorideTC2D6JAD40ACTIB
Carnauba WaxR12CBM0EIZIACT
Silicon DioxideETJ7Z6XBU4IACT
Croscarmellose SodiumM28OL1HH48IACT
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
Dibasic Calcium Phosphate DihydrateO7TSZ97GEPIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
Egg Phospholipids1Z74184RGVIACT
Magnesium Stearate70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
Polyethylene Glycol 400B697894SGQIACT
Polysorbate 806OZP39ZG8HIACT

Source Document#

Source XML · Source PDF

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
253539c9-9c6e-42d7-a31f-c970e0a05991079de233-aacb-47d3-90fe-d66f1ca7bb152020-04-23WarningsExact identifier
spl id: 253539c9-9c6e-42d7-a31f-c970e0a05991
spl set id: 079de233-aacb-47d3-90fe-d66f1ca7bb15

Reported adverse events (FAERS/openFDA)#

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