Assured Allergy Relief

Manufacturer
Spirit Pharmaceutical LLC | Elysium Pharmaceutical Ltd
Effective date
2022-11-21
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:47:13

Label at a glance#

ProductAssured Allergy Relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure11 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing 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 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 years of age

Storage and handling

store at controlled room temperature 15°-30° C (59°-86° F) protect from moisture and light see end flap for expiration date and lot number each tablet contains calcium 24 mg

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
    • itchy, watery eyes
    • sneezing
    • itching of the nose or throat
  • 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
  • trouble urinating due to an enlarged prostate gland
  • glaucoma

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 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.

Directions

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 over1 to 2 tablets
children 6 to under 12 years of age1 tablet
children under 6 years of agedo not use this product in children under 6 years of age

Other information

STORAGE AND HANDLING SECTION

  • store at controlled room temperature 15°-30° C (59°-86° F)
  • protect from moisture and light
  • see end flap for expiration date and lot number
  • each tablet contains calcium 24 mg

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C red # 27 Al lake, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY
GREENBRIER INTERNATIONAL, INC.
500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

PRINCIPAL DISPLAY PANEL - 25 mg Tablet Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ASSURED™

COMPARE TO ACTIVE INGREDIENT OF
BENADRYL ® ALLERGY ULTRATAB ®*

Allergy

  • Diphenhydramine HCl 25 mg
    Antihistamine

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

Actual Size

36 tablets

Principal Display Panel - 25 mg Tablet Bottle Carton
Principal Display Panel - 25 mg Tablet Bottle Carton

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68210-100268210-1002-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

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
29a7bbb5-a640-edae-e063-6294a90aa233ec0863eb-2a59-4968-b96e-a3b02b1f241b2024-12-19WarningsExact identifier
spl set id: ec0863eb-2a59-4968-b96e-a3b02b1f241b

Reported adverse events (FAERS/openFDA)#

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