Allergy Relief: Package Insert and Label Information

ALLERGY RELIEF- diphenhydramine hydrochloride capsule
Geiss, Destin & Dunn 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.

Active ingredient (in each banded capsule)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • itching of the nose or throat
  • itchy, watery eyes
  • sneezing
• 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

• glaucoma
• a breathing problem such as emphysema or chronic bronchitis
• 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
• avoid alcoholic beverages
  
• alcohol, sedatives, and tranquilizers may increase drowsiness
• use caution when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

If pregnant of 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
• 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

• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN OR IF RED BAND AROUND CAPSULE IS BROKEN OR MISSING
• 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

butylparaben, corn starch, D&C red #28, edible ink, FD&C blue #1, FD&C red #40, gelatin, lactose anhydrous, magnesium stearate, methylparaben, polysorbate 80, propylparaben, silicon dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

GOODSENSE®

NDC 50804-091-08

Allergy Relief

Diphenhydramine HCl, 25 mg
Antihistamine

Sneezing,

Itchy, Watery Eyes
Runny Nose,
Itchy Throat

*Compare to the active ingredient of Benadryl ®

100% SATISFACTION GUARANTEED

24 Capsules

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN OR BROKEN OR IF RED BAND AROUND CAPSULE IS BROKEN OR MISSING

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

50844 ORG111719008

Distributed by:
Geiss, Destin & Dunn, Inc., A Perrigo Company
Peachtree City, GA 30269
www.PerrigoDirect.com
(1-800-426-9391)
GoodSense® is a registered trademark ofL. Perrigo Company

Good Sense 44-190

ALLERGY RELIEF diphenhydramine hcl capsule

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50804-091 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 BUTYLPARABEN STARCH, CORN D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN ANHYDROUS LACTOSE MAGNESIUM STEARATE METHYLPARABEN POLYSORBATE 80 PROPYLPARABEN SILICON DIOXIDE

Product Characteristics Color PINK, WHITE Score no score Shape CAPSULE Size 14mm Flavor Imprint Code 44;107 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50804-091-08 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK 1 12 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (50804-091-08)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 06/02/2020

Labeler — Geiss, Destin & Dunn Inc. (076059836)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		868734088	MANUFACTURE (50804-091), PACK (50804-091)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		967626305	PACK (50804-091)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		832867837	PACK (50804-091)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		038154464	PACK (50804-091)

Revised: 05/2020 Geiss, Destin & Dunn Inc.