Health Mart Allergy Tablets

Manufacturer
Strategic Sourcing Services LLC
Effective date
2019-09-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 00:12:01

Label at a glance#

ProductAllergy
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

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

Storage and handling

each tablet contains: calcium 25 mg/tablet store at room temperature 15°-30°C (59°-86°F) protect from light and moisture do not use if imprinted safety seal under cap is broken or missing *This product is not manufactured or distributed by McNeil Consumer Healthcare, Division of McNeil-PPC, Inc., owner of the registered trademark Benadryl Allergy ULTRATAB

Label contents#

Full prescribing information#

Active Ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25mg

Purpose

OTC - PURPOSE SECTION

Antihistimine

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves symptoms due to hay fever or other upper respiratory allergies:

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

Warnings - Do not use

WARNINGS 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 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. (1-800-222-1222)

DOSAGE & ADMINISTRATION SECTION

 take every 4 to 6 hours
do not take more than 6 doses in 24 hours

adults and children 12 years of age and over  1 to 2 tablets
children 6 to under 12 years of age    1 tablet
children under 6 years of age        do not use this product in children under 6
children under 4 years of age        do not use

STORAGE AND HANDLING SECTION

each tablet contains: calcium 25 mg/tablet

store at room temperature 15°-30°C (59°-86°F)

protect from light and moisture

do not use if imprinted safety seal under cap is broken or missing

*This product is not manufactured or distributed by McNeil Consumer Healthcare, Division of McNeil-PPC, Inc., owner of the registered trademark Benadryl Allergy ULTRATAB

Inactive Ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, DandC Red No. 27 Aluminum Lake, dibasic calcium phosphate dihydrate, hypromellose, lecithin*, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80, polyvinyl alcohol*, purified water*, talc*, and titanium dioxide. *contains one or more of these ingredients

Questions or Comments

OTC - QUESTIONS SECTION

Call toll free 1-877-753-3935 Monday through Friday 9AM – 5PM EST

Distributed by:
PL Developments
Westbury, NY 11590, USA

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 59726-690-01

*Compare to the active ingredient in
Benadryl® Allergy ULTRATAB®

Antihistimine Allergy Tablets
Diphenhydramine Hydrochloride 25mg

For Allergy Relief
Sneezing, Itchy, Watery Eyes
Runny Nose, Itchy Throat

100 tablets

Product Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


Diphenhydramine Hydrochloride
Diphenhydramine Hydrochloride

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62011-0058-1EA - Each62011-0058dc32abb5-35f2-47b2-87ce-e783146b953312012-07-24
62011-0058-3EA - Each62011-0058651cbb78-f3e2-43f9-b915-6df86402ea5812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD403
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83M3
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O69333
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEP3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZ3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH483
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6K3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I303
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQ3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J9903
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU43
TALCINACTIVE INGREDIENT7SEV7J4R1U3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP3
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62011-005862011-0058-3, 62011-0058-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 398 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, FILM COATED / ORAL20 mgExact identifier — unii candidate
36 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION / ORAL907 mgExact identifier — unii candidate
78 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48CAPSULE, DELAYED RELEASE PELLETS / ORAL127 mgExact identifier — unii candidate
22 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPFILM, EXTENDED RELEASE / TRANSDERMALNAExact identifier — unii candidate
40 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / INTRAVITREAL0.02 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION/ DROPS / ORAL23 mgExact identifier — unii candidate
78 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, FOR SUSPENSION / ORAL24 mgExact identifier — unii candidate
35 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZOINTMENT / TOPICALNAExact identifier — unii candidate
11 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii candidate
49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, DELAYED RELEASE PARTICLES / ORAL580 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30INSERT / VAGINAL69 mgExact identifier — unii candidate
39 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48GRANULE / ORAL150 mgExact identifier — unii candidate
22 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, COATED / ORAL320.75 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UPOWDER / TOPICAL9235 mgExact identifier — unii candidate
35 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE / ORAL13440 mgExact identifier — unii candidate
36 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER / ORAL602 mgExact identifier — unii candidate
49 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii candidate
22 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPOWDER / RESPIRATORY (INHALATION)2 mgExact identifier — unii candidate
40 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS900 mgExact identifier — unii candidate
78 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30GRANULE, FOR SUSPENSION / ORAL14 mgExact identifier — unii candidate
39 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, CHEWABLE / ORAL216 mgExact identifier — unii candidate
22 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
78 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET, CHEWABLE / ORAL53 mgExact identifier — unii candidate
10 equally ranked IID candidates
TALCTALC7SEV7J4R1UGRANULE, DELAYED RELEASE / ORAL525 mgExact identifier — unii candidate
35 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HLOTION / TOPICAL15 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL69 mgExact identifier — unii candidate
49 equally ranked IID candidates
TALCTALC7SEV7J4R1UPOWDER, FOR SUSPENSION / ORAL735 mgExact identifier — unii candidate
35 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / SUBLINGUAL17.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
TALCTALC7SEV7J4R1ULOZENGE / ORAL50 mgExact identifier — unii candidate
35 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER, FOR SUSPENSION / ORAL120 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4FILM, EXTENDED RELEASE / TRANSDERMAL49 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii candidate
39 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990TABLET, COATED / ORAL0.7 mgExact identifier — unii candidate
17 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQCREAM / TOPICAL10 %w/wExact identifier — unii candidate
36 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, LIQUID FILLED / ORAL24 mgExact identifier — unii candidate
78 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48CAPSULE / ORAL257 mgExact identifier — unii candidate
22 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, DELAYED RELEASE / ORAL420 mgExact identifier — unii candidate
35 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZCAPSULE, EXTENDED RELEASE / ORAL288 mgExact identifier — unii candidate
11 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4DROPS / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30IMPLANT / SUBCUTANEOUS0.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE, EXTENDED RELEASE / ORAL9 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, COATED / ORAL184 mgExact identifier — unii candidate
39 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOLOTION / TOPICAL0.1 %w/wExact identifier — unii candidate
27 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION / RECTAL315 mgExact identifier — unii candidate
78 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, COATED / ORAL224 mgExact identifier — unii candidate
22 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, EXTENDED RELEASE / ORAL5119 mgExact identifier — unii candidate
35 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPFILM, SOLUBLE / BUCCAL11 mgExact identifier — unii candidate
40 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, EXTENDED RELEASE / ORAL60 mgExact identifier — unii candidate
36 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CREAM / VAGINAL51 mgExact identifier — unii candidate
49 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPOWDER, FOR SUSPENSION / ORAL297 mgExact identifier — unii candidate
40 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQINJECTION, SOLUTION / INTRAMUSCULAR20.3 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTROCHE / ORAL300 mgExact identifier — unii candidate
28 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPFILM, SOLUBLE / ORAL2 mgExact identifier — unii candidate
40 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOINSERT / VAGINAL54.21 mgExact identifier — unii candidate
27 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, EXTENDED RELEASE / ORAL1472 mgExact identifier — unii candidate
27 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, COATED PELLETS / ORAL4.4 mgExact identifier — unii candidate
40 equally ranked IID candidates

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
481de4bb-5d7e-4155-8629-d9f19de4ca5ae08d0451-473d-434b-8f2a-dcd264cb967e2019-09-13WarningsExact identifier
spl id: 481de4bb-5d7e-4155-8629-d9f19de4ca5a
spl set id: e08d0451-473d-434b-8f2a-dcd264cb967e

Reported adverse events (FAERS/openFDA)#

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