Your browser does not support JavaScript! ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [KROGER COMPANY]
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ALLERGY (diphenhydramine hydrochloride) capsule
[Kroger Company]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections

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
itchy, watery eyes
itching of the nose or throat
temporarily relieves these symptoms due to the common cold:
runny nose
sneezing

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

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. (1-800-222-1222)

Directions

take every 4 to 6 hours
do not take more than 6 doses in 24 hours

adults and children 12 years and over

1 to 2 capsules

children 6 to under 12 years

1 capsule

children under 6 years

do not use this product in children under 6 years of age

Inactive ingredients

anhydrous lactose, benzyl alcohol, butylparaben, D&C red #28, edetate calcium disodium, edible ink, FD&C blue #1, FD&C red #40, gelatin, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium lauryl sulfate, sodium propionate

Questions or comments?

1-800-632-6900

Principal Display Panel

COMPARE TO the active ingredient of BENADRYL® ALLERGY

See top panel

Allergy Capsules

Diphenhydramine HCl 25 mg EACH

Antihistamine

Relieves:

Sneezing

Itchy, Watery Eyes

Itchy Throat

Runny Nose

100 CAPSULES

25 mg EACH

actual size

EASY TO SWALLOW

Allergy Capsules Image 1
Allergy Capsules Image 2
ALLERGY 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:30142-462
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
BENZYL ALCOHOL 
BUTYLPARABEN 
D&C RED NO. 28 
EDETATE CALCIUM DISODIUM 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
MAGNESIUM STEARATE 
METHYLPARABEN 
POLYSORBATE 80 
PROPYLPARABEN 
SODIUM LAURYL SULFATE 
SODIUM PROPIONATE 
Product Characteristics
ColorPINK (clear) , WHITE (clear) , RED (band) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint Code L462
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-462-6212 in 1 CARTON
12 in 1 BLISTER PACK
2NDC:30142-462-6724 in 1 CARTON
22 in 1 BLISTER PACK
3NDC:30142-462-781 in 1 CARTON
3100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/15/1990
Labeler - Kroger Company (006999528)

Revised: 3/2014
 
Kroger Company

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