ALLERGY RELIEF

ALLERGY RELIEF

Drug Labeling and Warnings

Drug Details

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ALLERGY RELIEF- diphenhydramine hydrochloride tablet, film coated 
Spirit Pharmaceutical 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

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 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

DISTRIBUTED BY:
MIDWOOD BRANDS, LLC

10611 MONROE RD,

MATTHEWS, NC 28105 USA

PRINCIPAL DISPLAY PANEL - 25 mg Tablet Blister Pack Carton

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COMPARE TO THE ACTIVE
INGREDIENT OF BENADRYL ®
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100% SATISFACTION
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Allergy Relief
Diphenhydramine HCl 25 mg
Antihistamine PRINCIPAL DISPLAY PANEL - 25 mg Tablet Blister Pack Carton

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

48
COATED MINITABS
(small size tablets)

ACTUAL SIZE

ALLERGY RELIEF 
diphenhydramine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68210-1001
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)  
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
ColorpinkScoreno score
ShapeOVALSize12mm
FlavorImprint Code S4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68210-1001-44 in 1 CARTON08/18/2016
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/18/2016
Labeler - Spirit Pharmaceutical LLC (179621011)
Establishment
NameAddressID/FEIBusiness Operations
ELYSIUM PHARMACEUTICALS LTD915664486manufacture(68210-1001)

Revised: 12/2019
 
Spirit Pharmaceutical LLC


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