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Allergy Antihistamine by SuperValu (Equaline)

Dosage form: tablet
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: SuperValu (Equaline)
NDC Code: 41163-690

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 25 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms of the common cold:

  • runny nose
  • sneezing 

temporarily relieves symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itching nose or throat
  • itchy, watery eyes

Warnings

Do not use
  • 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

  • glaucoma

  • difficulty in urination due to an enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking tranquilizers or sedatives.

When using this product
  • excitability may occur especially in children
  • drowsiness may occur

  • avoid alcoholic drinks

  • alcohol, sedatives, and tranquilizers may increase drowsiness

  • use caution when operating machinery or driving a motor vehicle

If pregnant of 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 over take 1 or 2 tablets 
 children 6 to under 12 years of age take 1 tablet
children under 6 years of ageconsult a doctor
 children under 4 years of age do not use

Other information
  • each tablet contains: calcium 25 mg/ tablet
  • store at room temperature 15°-30°C (59°-86°F)
  • protect from light and moisture

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Aluminum Lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80 and titanium dioxide

May also contain: polyvinyl alcohol and talc.

Principal Display Panel

Compare to Benadryl® Allergy ultratabs® Active Ingredient*

Allergy

Antihistamine

For allergy relief:

sneezing, itchy & watery eyes, runny nose & itchy throat

Diphenhydramine HCl 25 mg

*This product is not manufactured or distributed by McNeil Consumer Healthcare, Division of McNeil-PPC, Inc., owner of the registered trademark Benadryl® Allergy Ultratabs®

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

DISTRIBUTED BY SUPERVALU INC.

EDEN PRAIRIE, MN 55344 USA

PRODUCT OF USA

CONTACT US AT 1-877-932-7948, OR WWW.SUPERVALU-OUROWNBRANDS.COM

Product Label

Diphenhydramine HCl 25mg

ALLERGY  ANTIHISTAMINE
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-690
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
D&C RED NO. 27 
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 400 
POLYSORBATE 80 
POLYVINYL ALCOHOL 
TALC 
TITANIUM DIOXIDE 
ALUMINUM OXIDE 
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize12mm
FlavorImprint CodeT;61;V;25;S4
Contains    
Packaging
#Item CodePackage Description
1NDC:41163-690-242 BLISTER PACK (2 BLISTER PACK) in 1 CARTON
112 TABLET (12 TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33607/22/2010
Labeler - SuperValu (Equaline) (006961411)

Revised: 10/2012
 
SuperValu (Equaline)

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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