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allergy relief Childrens by SUPERVALU INC.

Dosage form: tablet, chewable
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 12.5mg
Labeler: SUPERVALU INC.
NDC Code: 41163-585

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.

Equaline 44-585

Active ingredient (in each chewable tablet)

Diphenhydramine HCl 12.5 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

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
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery
  • avoid alcoholic beverages
  • 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 (1-800-222-1222) right away.

Directions
  • find right dose on chart below
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times in 24 hours
Age (yr)
Dose (chewable tablets)
 children under 2 years do not use
children 2 to 5 years

do not use unless
directed by a doctor

children 6 to 11 years
1 to 2 chewable tablets
(12.5 mg to 25 mg)

adults and children 12 years
and over

2 to 4 chewable tablets
(25 mg to 50 mg)

Other information
  • avoid high humidity
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  •  store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose, sucrose

Questions or comments?

1-877-932-7948

Principal Display Panel

EQUALINE®

compare to
Children's Benadryl®
Chewables

active ingredient*

NDC 41163-585-44

children's
allergy relief
diphenhydramine HCl 12.5 mg
(antihistamine)

for ages 6-11
chewable
grape flavor

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

18 tablets

actual size

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

DOES NOT CONTAIN GLUTEN

*This product is not manufactured or distributed by
Johnson & Johnson Corporation, owner of the registered
trademark Children's Benadryl® chewables.

50844      REV0317A58544

100% Quality
GUARANTEED

Like it or let us make it right.
That's our quality promise.
877-932-7948

supervaluprivatebrands.com
DISTRIBUTED BY SUPERVALU INC.
EDEN PRAIRIE, MN 55344 USA

Equaline 44-585


ALLERGY RELIEF  CHILDRENS
diphenhydramine hcl tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-585
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 27 
D&C RED NO. 30 
STEARIC ACID 
SUCRALOSE 
DEXTROSE MONOHYDRATE 
FD&C BLUE NO. 1 
MAGNESIUM STEARATE 
MANNITOL 
SUCROSE 
ETHYLCELLULOSE, UNSPECIFIED 
HYDROXYPROPYL CELLULOSE, UNSPECIFIED 
Product Characteristics
ColorPURPLEScoreno score
ShapeROUNDSize12mm
FlavorGRAPEImprint Code44;585
Contains    
Packaging
#Item CodePackage Description
1NDC:41163-585-443 BLISTER PACK in 1 CARTON
16 TABLET, CHEWABLE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/20/2009
Labeler - SUPERVALU INC. (006961411)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(41163-585)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(41163-585)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(41163-585)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(41163-585)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(41163-585)

 
SUPERVALU INC.

← See all allergy relief Childrens brands

Medically reviewed on Jul 27, 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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