TopCare health Dye-Free Allergy Relief

Set ID
44aa1533-b790-478d-be38-add08c824d6d
Manufacturer
TOPCO ASSOCIATES LLC
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:47:25

Key Label Information

Active Ingredients And Purpose

Active ingredient (in each capsule)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

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 temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing, runny nose

Warnings

Warnings

Directions And Dosage

Directions

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 softgels children 6 to under 12 years of age - take 1 softgel children under 6 years of age - do not use

Other Label Information

Inactive ingredients

gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol-sorbitan solution, titanium dioxide

Questions or comments?

Call 1-888-333-9792

PRINCIPAL DISPLAY PANEL

Compare to Benadryl® Dye-Free LIQUI-GELS® active ingredient* Allergy Relief Diphenhydramine HCl 25 mg/Antihistamine Dye-Free temporarily Relieves: Sneezing Runny Nose Itchy, Watery Eyes Itchy Nose or Throat Softgels *This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl®, or Catalent Pharma Solutions, Inc., owner of the registered trademark LIQUI-GELS®.

Products

NDC Codes

Ingredients

NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

Complete SPL Sections

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 temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing, runny nose

Warnings

WARNINGS SECTION

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 softgels children 6 to under 12 years of age - take 1 softgel children under 6 years of age - do not use

Other information

OTHER SAFETY INFORMATION

store between 20-25ºC (68 to 77°F). Avoid high humidityandexcessive heat. Protect from light, heat, humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol-sorbitan solution, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-333-9792

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Benadryl® Dye-Free LIQUI-GELS® active ingredient* Allergy Relief Diphenhydramine HCl 25 mg/Antihistamine Dye-Free temporarily Relieves: Sneezing Runny Nose Itchy, Watery Eyes Itchy Nose or Throat Softgels *This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl®, or Catalent Pharma Solutions, Inc., owner of the registered trademark LIQUI-GELS®.

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
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otc0c070793-1501-78f9-e063-6294a90a335d.xml2023-12-09
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otc9decf8d9-fb56-24a4-e053-2a95a90abe96.xml2020-02-07
otcUntitled1.jpg2020-02-07