ALLERGY RELIEF- diphenhydramine hcl tablet, film coated
Harmon Store 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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Core Values 44-329 Delisted

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
- itchy, watery eyes
- sneezing
- 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
difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

marked drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic beverages
use caution 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

do not take more than directed
take every 4 to 6 hours, or as directed by a doctor
do not take more than 6 times 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 30 mg
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
protect from moisture
see end flap for expiration date and lot number

Inactive ingredients

corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon
dioxide, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

CORE VALUES™

Compare to active ingredient in
Benadryl® Allergy ULTRATAB®†

Allergy Relief

Diphenhydramine HCl 25 mg
Antihistamine

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

Actual Size

24 coated mini-tabs

†This product is not manufactured or distributed
by Johnson & Johnson Corporation, owner of the
registered trademark Benadryl® Allergy ULTRATAB®.

50844 REV0721B32908

Distributed by: Liberty Procurement Co. Inc.,
650 Liberty Ave., Union NJ 07083 U.S.A.
Satisfaction Guaranteed Or Your Money Back
Visit us at www.facevalues.com

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Core Values 44-329 REV0721B

ALLERGY RELIEF
diphenhydramine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63940-329
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
STARCH, CORN (UNII: O8232NY3SJ)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	pink	Score	no score
Shape	OVAL	Size	11mm
Flavor		Imprint Code	44;329
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63940-329-12	1 in 1 CARTON	03/02/1990	10/07/2023
1		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:63940-329-08	2 in 1 CARTON	03/02/1990	10/07/2023
2		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:63940-329-03	1 in 1 PACKAGE	03/02/1990	10/26/2021
3		10 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	03/02/1990	10/07/2023

Labeler - Harmon Store Inc. (804085293)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(63940-329)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	manufacture(63940-329) , pack(63940-329)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(63940-329)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	manufacture(63940-329)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(63940-329)

Revised: 5/2023

Document Id: 2b5309b8-2849-4893-aa6d-95f8a116643d

Set id: 61a00a2c-118e-4e19-9166-4a0766362482

Version: 9

Effective Time: 20230509

Harmon Store Inc.