ALLERGY RELIEF- diphenhydraime hcl tablet, film coated 
Spirit Pharmaceuticals LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Allergy Relief

Drug Facts

Purpose

Antihistamine

Active Ingredient


Diphenhydramine HCl 25 mg

Uses

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies • runny nose • sneezing • itchy, watery eyes • 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 • glaucoma • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

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. (1-800-222-1222)

Directions

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

 adults & children 12 years & over1 to 2 tablets 
 children 6 to under 12 years1 tablet
 children under 6 yearsdo not use this product in children under 6 years of age

Other information

• each tablet contains: calcium 24 mg • store between 15–30°C (59–86°F) • protect from moisture and light

Inactive ingredients

Colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C Red No. 27 Aluminum lake, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Questions or comments?

1-888-333-9792

Distributed by:

CABINET HEALTH P.B.C.

Pouch Label

PACKAGE NOT CHILD-RESISTANT

CABINET

Allergy Relief

Active Ingredient
Diphenhydramine HCl 25 mg**

**May cause drowsiness

Relieves:
Sneezing
Itchy, Watery Eyes
Runny Nose
Itchy Throat

Includes:

1 x Magnetic Label

1 x Drug Facts Booklet

30 x Tablets

CABINET: The Sustainable Healthcare Co.™

Pouch


ALLERGY RELIEF 
diphenhydraime hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-4169
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)  
DICALCIUM CITRATE (UNII: LGH2B6RC26)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorpinkScoreno score
ShapeCAPSULESize11mm
FlavorImprint Code S4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68210-4169-330 in 1 POUCH; Type 0: Not a Combination Product11/16/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/16/2021
Labeler - Spirit Pharmaceuticals LLC (179621011)
Registrant - Spirit Pharmaceuticals LLC (179621011)
Establishment
NameAddressID/FEIBusiness Operations
Elysium Pharmaceuticals Ltd915664486manufacture(68210-4169)

Revised: 11/2021
Document Id: d0ed26cb-6d65-0a47-e053-2995a90a53c4
Set id: 61c340e5-ace6-4ec1-9d3e-e965fca1263a
Version: 2
Effective Time: 20211116
 
Spirit Pharmaceuticals LLC