ALLERGY RELIEF- diphenhydramine hcl capsule
Shopko Stores Operating Co., LLC

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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Shopko Allergy Relief 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
•: 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

•: 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 capsules
children 6 to under 12 years	1 capsule
children under 6 years	do not use

Other information

•: store at 20-25°C (68-77°F). Avoid high humidity. Protect from light.

Inactive ingredients

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

Questions or comments?

1-800-719-9260

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Compare to Benadryl® active ingredient

ALLERGY RELIEF

ANTIHISTAMINE

Diphenhydramine HCl Capsules 25 mg Each

Relieves: Sneezing; Itchy, Watery Eyes; Runny Nose; Itchy Throat

100 CAPSULES

Actual Size

ALLERGY RELIEF
diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37012-462
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
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37012-462-78	1 in 1 CARTON	10/07/2016	11/30/2020
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	part341	10/07/2016	11/30/2020

Labeler - Shopko Stores Operating Co., LLC (023252638)

Revised: 9/2022

Document Id: 44db09b0-1a0b-4e27-896d-7dbf8a00962e

Set id: cea9db2d-d8d4-42d5-a87b-878bf662be94

Version: 3

Effective Time: 20220927

Shopko Stores Operating Co., LLC