ASSURED ALLERGY RELIEF- diphenhydramine hydrochloride tablet, film coated 
Spirit Pharmaceutical LLC

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Assured™ Allergy Relief

Drug Facts

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

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

Warnings

Do not use

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

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

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

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

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • 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

  • 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

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?

1-888-333-9792

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

PRINCIPAL DISPLAY PANEL - 25 mg Tablet Bottle Carton

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
ASSURED ALLERGY RELIEF 
diphenhydramine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-1002
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorpinkScoreno score
ShapeOVALSize11mm
FlavorImprint Code S4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68210-1002-31 in 1 CARTON07/01/2016
136 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01707/01/201612/07/2023
Labeler - Spirit Pharmaceutical LLC (179621011)
Establishment
NameAddressID/FEIBusiness Operations
Elysium Pharmaceutical Ltd915664486manufacture(68210-1002)

Revised: 12/2023
Document Id: 0bf31911-9c21-24fc-e063-6394a90a6386
Set id: ec0863eb-2a59-4968-b96e-a3b02b1f241b
Version: 7
Effective Time: 20231207
 
Spirit Pharmaceutical LLC