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Allergy Relief by Kareway Product, Inc.

Dosage form: tablet
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Kareway Product, Inc.
NDC Code: 67510-0158

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.

Drug Facts

Active ingredient (in each tablet)

Diphenhydramine HCL 25mg

Purpose

Antihistamine

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 with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

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
  • excitability may occur, especially in children
  • be careful when driving a motor vehicle or operating machinery

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose get medical help or contact a Poison Control Center right away.

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

adults and children 12 years of age and over25 mg to 50 mg (1 to 2 tablets)
children 6 to under 12 years of age12.5** to 25 mg (1 tablet)
children under 6 years of ageask a doctor

**12.5 mg dosage strength is not available in this package. Do not attempt to break tablets.

Other information
  • each tablet contains:calcium 0.1mg
  • store at 59° to 77°F in a dry place
  • protect from light

Inactive ingredients

microcrystalline cellulose, lactose anhydrous, sodium starch glycolate, pregelatinized starch, dibasic calcium phosphate dihydrate, crospovidone, stearic acid, magnesium stearate, hypromellose, polyethyleneglycol, titanium dioxide, ethanol

Package label

Allergy Relief

ALLERGY RELIEF 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0158
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE WAX 
ANHYDROUS LACTOSE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STARCH, CORN 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
CROSPOVIDONE 
STEARIC ACID 
MAGNESIUM STEARATE 
HYPROMELLOSES 
FD&C RED NO. 3 
POLYETHYLENE GLYCOLS 
TITANIUM DIOXIDE 
ETHANETHIOL 
Product Characteristics
ColorblueScoreno score
ShapeROUNDSize9mm
FlavorImprint CodeBE
Contains    
Packaging
#Item CodePackage Description
1NDC:67510-0158-22 BLISTER PACK (BLISTER PACK) in 1 BOX
112 TABLET (TABLET) in 1 BLISTER PACK
2NDC:67510-0158-44 BLISTER PACK (BLISTER PACK) in 1 BOX
212 TABLET (TABLET) in 1 BLISTER PACK
3NDC:67510-0158-02 BLISTER PACK (BLISTER PACK) in 1 BOX
310 TABLET (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/18/2011
Labeler - Kareway Product, Inc. (121840057)

 
Kareway Product, Inc.

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Medically reviewed on Feb 15, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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