ALLERGY- diphenhydramine hydrochloride tablet 
Kroger Company

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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Kroger Co. Allergy Tablets Drug Facts

Active ingredient (in each tablet)

Diphenhydramine hydrochloride 25 mg

Purpose

Antihistamine

Uses

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itchy nose or throat
  • temporarily relieves these symptoms of the common cold:
  • runny nose
  • sneezing

Warnings

Do not use

  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy

Ask a doctor before use if you have

  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

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
  • excitability may occur, especially in children
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • 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 overdose, get medical help or contact a Poison Control Center right away.

Directions

  • take every 4 to 6 hours, not more than 6 doses in 24 hours
adults and children 12 years of age and over1 or 2 tablets
children 6 to under 12 years of age1 tablet
children 4 to under 6 years of agedo not use unless directed by a doctor
children under 4 years of agedo not use

Other information

  • each tablet contains: calcium 20 mg
  • store at 20°-25°C

Inactive ingredients

carnauba wax, crospovidone, D&C red no. 27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

1-800-632-6900

Principal Display Panel

COMPARE TO active ingredient of BENADRYL® ALLERGY ULTRATAB® - See end panel

SEE NEW WARNING AND DOSING DIRECTIONS

Allergy Tablets

Antihistamine

Diphenhydramine Hydrochloride

Sneezing

Itchy, Watery Eyes

Runny Nose

Itchy Throat

Easy to Swallow

Allergy Tablets Carton Image 1

Allergy Tablets Carton Image 1

Allergy Tablets Carton Image 2

Allergy Tablets Carton Image 2

ALLERGY 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:30142-479
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
CROSPOVIDONE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYSORBATE 80 
STEARIC ACID 
TITANIUM DIOXIDE 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
Product Characteristics
ColorPINK (dark) Scoreno score
ShapeCAPSULESize10mm
FlavorImprint Code L479
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-479-622 in 1 CARTON
112 in 1 BLISTER PACK
2NDC:30142-479-674 in 1 CARTON
212 in 1 BLISTER PACK
3NDC:30142-479-781 in 1 CARTON
3100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/15/1987
Labeler - Kroger Company (006999528)

Revised: 12/2011
Document Id: a2f7cb2b-17ef-4ed5-abf7-0a41cfe362b2
Set id: a2f7cb2b-17ef-4ed5-abf7-0a41cfe362b2
Version: 1
Effective Time: 20111207
 
Kroger Company