ALLERGY RELIEF- diphenhydramine hydrochloride tablet, film coated

ALLERGY RELIEF by

Drug Labeling and Warnings

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

Drug Details [pdf]

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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 20°-25°C (68°-77°F)
• protect from moisture and light
• see end flap for expiration date and lot number

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

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DISTRIBUTED BY:
MIDWOOD BRANDS, LLC

10611 MONROE RD,

MATTHEWS, NC 28105 USA

PRINCIPAL DISPLAY PANEL - 25 mg Tablet Blister Pack Carton

FAMILYwellness™

COMPARE TO THE ACTIVE
INGREDIENT OF BENADRYL ®
ALLERGY ULTRATAB ®*

100% SATISFACTION
OR YOUR MONEY BACK
GUARANTEED

Allergy Relief
Diphenhydramine HCl 25 mg
Antihistamine

For Relief of: Runny Nose
Sneezing, Itchy Throat
Itchy, Watery Eyes

48
COATED MINITABS
(small size tablets)

ACTUAL SIZE

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF 
diphenhydramine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68210-1001
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)
WATER (UNII: 059QF0KO0R)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68210-1001-4	4 in 1 CARTON	08/18/2016
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 68210-1001-1	1 in 1 CARTON	02/12/2020
2		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 68210-1001-2	1 in 1 CARTON	02/12/2020
3		100 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 68210-1001-3	1 in 1 CARTON	02/12/2020
4		115 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/18/2016

Labeler - Spirit Pharmaceutical LLC (179621011)

Establishment
Name	Address	ID/FEI	Business Operations
ELYSIUM PHARMACEUTICALS LTD		915664486	manufacture(68210-1001)