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Allergy relief by SuperValu (Equaline)

Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: SuperValu (Equaline)
NDC Code: 41163-970

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 capsule)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

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

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

temporarily relieves these symptoms of 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
  • 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
  • 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.

Directions
  • take every 4 to 6 hours
  • do not take more than 6 times in 24 hours
 adults and children 12 years of age and over take 1 to 2 capsules 
 children 6 to under 12 years of age take 1 capsule
children under 6 years of age do not use

Other information
  • read the directions, warnings and accompanying label information before use
  • store at room temperature 15° to 30°C (59° to 86°F)
  • protect from light

Inactive ingredients

D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose and starch.

Questions or comments?

Call toll free 1-877-932-7948

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Compare to Benadryl® Active Ingredient*

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

Allergy capsules

Diphenhydramine HCl 25 mg

Antihistamine

For allergy relief of:

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING OR IF RED BAND AROUND CAPSULE IS BROKEN OR MISSING

Product Label

Diphenhydramine HCl 25 mg

ALLERGY  RELIEF
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-970
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 28 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
LACTOSE 
STARCH, CORN 
Product Characteristics
ColorPINK, WHITEScoreno score
ShapeCAPSULESize14mm
FlavorImprint CodeCPC;835
Contains    
Packaging
#Item CodePackage Description
1NDC:41163-970-011 BOTTLE (1 BOTTLE) in 1 BOX
1100 CAPSULE (100 CAPSULE) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33608/15/2011
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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