FDA.reportPublic FDA data

Allergy Relief

Manufacturer
TOP CARE (Topco Associates LLC)
Effective date
2020-11-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:07:39

Label at a glance#

ProductAllergy Relief Dye Free
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

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

Dosage and administration

take every 4 to 6 hours do not take more than 6 doses in 24 hours swallow whole; do not crush, chew or dissolve adults and children 12 years of age and over  take 1 to 2 capsules  children 6 to under 12 years of age  take 1 capsule children under 6 years of age  do not use

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • 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

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 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
  • swallow whole; do not crush, chew or dissolve
adults and children 12 years of age and over take 1 to 2 capsules 
children 6 to under 12 years of age take 1 capsule
children under 6 years of age do not use

Other information

OTHER SAFETY INFORMATION

  • store between 15-30ºC (59° to 86°F) 
  • Protect from light, heat, humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

edible dye free ink, gelatin, glycerin, polyethylene glycol, purified water, sorbitol-sorbitan solution

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-888-423-0139

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO BENADRYL® LIQUI-GELS® ACTIVE INGREDIENT*

DYE-FREE

Allergy Relief

DIPHENHYDRAMINE HCl 25 mg - ANTIHISTAMINE

RELIEF OF:

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

SOFTGELS**

**Liquid-Filled Capsules

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl®, Catalent Pharma Solutions, Inc., owner of the registered trademark LIQUI-GELS®.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

©TOPCO PLVA0218

topcare@topco.com

www.topcarebrand.com

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TOPCARE HEALTH Dye-Free Allergy Relief
TOPCARE HEALTH Dye-Free Allergy Relief

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-48336800-483-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
SORBITAN6O92ICV9RUIACT

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
5a53e069-8e44-4e12-b36f-215f4ec696ee1193fcfd-b638-447b-ac31-9f7ed2b6f5fa2020-11-10WarningsExact identifier
spl id: 5a53e069-8e44-4e12-b36f-215f4ec696ee
spl set id: 1193fcfd-b638-447b-ac31-9f7ed2b6f5fa

Reported adverse events (FAERS/openFDA)#

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