VALUMEDS ALLERGY RELIEF- diphenhydramine hydrochloride 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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ValuMeds 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. 1(800)222-1222

Directions

  • take every 4 to 6 hours or as directed by a doctor
  • do not take more than 6 times 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

  • each tablet contains calcium 24 mg
  • store at controlled room temperature 15°-30°C (59°-86°F)
  • protect from moisture and light

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C red No 27, dicalcium phosphate, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Questions or comments?

1-888-333-9792

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Benadryl®.

Distributed By:

Spirit Pharmaceuticals, LLC

Ronkonkoma, NY 11779

ORIG 06/17

Principal Display Panel - 600 ct Bottle Label

VALUMEDS™

Compare to the active ingredient in  Benadryl® Allergy Tablets*

ALLERGY RELIEF 

Antihistamine 
Diphenhydramine HCl 25 mg

For the temporary relief of:

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

600 TABLETS

Principal Display Panel

VALUMEDS ALLERGY RELIEF 
diphenhydramine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-1200
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)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
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)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorpinkScoreno score
ShapeCAPSULESize12mm
FlavorImprint Code S4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68210-1200-0600 in 1 BOTTLE; Type 0: Not a Combination Product04/17/2018
2NDC:68210-1200-22 in 1 CARTON09/18/2020
212 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/16/2018
Labeler - Spirit Pharmaceuticals LLC (179621011)
Establishment
NameAddressID/FEIBusiness Operations
ELYSIUM PHARMACEUTICALS LIMITED915664486manufacture(68210-1200)

Revised: 9/2020
Document Id: af95e6dd-71d6-b01f-e053-2995a90a1e88
Set id: 39936c91-b395-4a96-b9b9-6e961fdcdbaf
Version: 2
Effective Time: 20200918
 
Spirit Pharmaceuticals LLC