EQUALINE ALLERGY - diphenhydramine hydrochloride capsule
Supervalu Inc

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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Active ingredient (in each capsule)

Diphenhydramine hydrochloride 25 mg

Purpose

Antihistamine

Uses (Blister Carton)

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

Uses (Bottle Carton)

temporarily relieves symptoms due to hay fever, other upper respiratory allergies and the common cold

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

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

Ask a doctor or pharmacist before use if you are

taking tranquilizers or sedatives

When using this product

excitability may occur, especially in children
marked drowsiness may occur
avoid alcoholic drinks
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 over	1 or 2 capsules
children 6 to under 12 years of age	1 capsule
children 4 to under 6 years of age	do not use unless directed by a doctor
children under 4 years of age	do not use

Other information (Blister Carton)

store at room temperature (59°-86°F)
protect from moisture

Inactive ingredients

benzyl alcohol, butylparaben, D&C red no. 28, D&C yellow no. 10, edetate calcium disodium, edible ink, FD&C blue no. 1, FD&C blue no. 2, FD&C red no. 40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, silicon dioxide, sodium lauryl sulfate, sodium propionate

Questions or comments?

1-877-932-7948

Principal Display Panel

Compare to Benadryl® Allergy Kapseals® active ingredient

Allergy

Capsules

Antihistamine

Diphenhydramine Hydrochloride 25 mg

For Allergy Relief:

Sneezing

Itchy, Watery Eyes

Runny Nose

Itchy Throat

See New Warning and Dosing Directions

Easy to Swallow

Allergy Capsules Carton

EQUALINE ALLERGY
diphenhydramine hydrochloride capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41163-462
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL
BUTYLPARABEN
D&C RED NO. 28
D&C YELLOW NO. 10
EDETATE CALCIUM DISODIUM
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
GELATIN
LACTOSE
MAGNESIUM STEARATE
METHYLPARABEN
POLYSORBATE 80
PROPYLPARABEN
SILICON DIOXIDE
SODIUM LAURYL SULFATE
SODIUM PROPIONATE

Product Characteristics
Color	PINK (clear) , WHITE (clear) , RED (band)	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	L462
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:41163-462-78	1 BOTTLE ( BOTTLE) in 1 CARTON	contains a BOTTLE
1		100 CAPSULE ( TABLET) in 1 BOTTLE	This package is contained within the CARTON (41163-462-78)
2	NDC:41163-462-68	3 BLISTER PACK ( BLISTER PACK) in 1 CARTON	contains a BLISTER PACK
2		12 CAPSULE ( TABLET) in 1 BLISTER PACK	This package is contained within the CARTON (41163-462-68)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/17/2004

Labeler - Supervalu Inc (006961411)

Revised: 11/2009 Supervalu Inc