Allergy: Package Insert and Label Information

ALLERGY- diphenhydramine hydrochloride tablet
Kroger Company

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.

Active ingredient (in each tablet)

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
itchy nose or throat
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

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

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, or as directed by a doctor
do not take more than 6 doses in 24 hours

adults and children 12 years and over

1 to 2 tablets

children 6 to under 12 years

1 tablet

children under 6 years

do not use

Other information

each tablet contains: calcium 20 mg
store at 20-25° C (68-77° F). Avoid high humidity. Protect from light.
do not use if blister unit is broken or torn

Inactive ingredients

carnauba wax, crospovidone, D&C red no. 27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

1-800-632-6900

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Allergy Tablets

Diphenhydramine HCl 25 mg EACH

Antihistamine

Relieves:

Sneezing

Itchy, Watery eyes

Itchy Throat

Runny Nose

24 TABLETS 25 mg EACH

actual size

EASY TO SWALLOW

Kroger Allergy Tablets image
(click image for full-size original)
ALLERGY
diphenhydramine hydrochloride tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-479
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
CARNAUBA WAX
CROSPOVIDONE (15 MPA.S AT 5%)
D&C RED NO. 27
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
STEARIC ACID
TITANIUM DIOXIDE
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
Product Characteristics
Color PINK (dark) Score no score
Shape OVAL Size 10mm
Flavor Imprint Code L479
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:30142-479-62 24 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (30142-479-62)
2 NDC:30142-479-67 48 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (30142-479-67)
3 NDC:30142-479-78 1 BOTTLE in 1 CARTON contains a BOTTLE
3 100 TABLET in 1 BOTTLE This package is contained within the CARTON (30142-479-78)
4 NDC:30142-479-79 1 BOTTLE in 1 CARTON contains a BOTTLE
4 400 TABLET in 1 BOTTLE This package is contained within the CARTON (30142-479-79)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 09/15/1987
Labeler — Kroger Company (006999528)

Revised: 11/2019 Kroger Company

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