VALUMEDS ALLERGY RELIEF- diphenhydramine hydrochloride tablet, film coated

VALUMEDS ALLERGY RELIEF by

Drug Labeling and Warnings

VALUMEDS ALLERGY RELIEF by is a Otc medication manufactured, distributed, or labeled by Spirit Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 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

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

VALUMEDS ALLERGY RELIEF 
diphenhydramine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68210-1200
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
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)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	pink	Score	no score
Shape	CAPSULE	Size	12mm
Flavor		Imprint Code	S4
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68210-1200-0	600 in 1 BOTTLE; Type 0: Not a Combination Product	04/17/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/16/2018

Labeler - Spirit Pharmaceuticals LLC (179621011)

Establishment
Name	Address	ID/FEI	Business Operations
ELYSIUM PHARMACEUTICALS LIMITED		915664486	manufacture(68210-1200)