ALLERGY RELIEF- diphenhydramine hcl capsule
EQUALINE (SuperValu)

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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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

Principal Display Panel

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41163-970
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Ingredient Name	Strength
Inactive Ingredients
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	PINK, WHITE	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	CPC;835
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41163-970-01	1 in 1 BOX	08/15/2011	08/15/2020
1		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part336	08/15/2011	08/15/2020

Labeler - EQUALINE (SuperValu) (006961411)

Revised: 7/2019

Document Id: 28bbb3af-6b36-4e6d-bcf2-9cf5345151d4

Set id: 4c1469a1-1b7e-43d6-9966-03f1e88e4a32

Version: 2

Effective Time: 20190719

EQUALINE (SuperValu)