ALLERGY SOFTGEL- diphenhydramine hcl capsule, liquid filled
AiPing Pharmaceutical, 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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Allergy (Diphenhydramine HCl) Dry-Free Softgels

Active ingredient

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
do not take more than 6 doses in 24 hours

adults and children 12 years and older	1 to 2 softgels
children 6 to under 12 years	1 softgel
children under 6 years	do not use this product in children under 6 years of age

OTHER INFORMATION

store between 20-25°C (68-77°F). Avoid high humidity and excessive heat. Protect from light.
do not use if carton is open or blister unit is broken

Inactive Ingredients

gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution and white edible ink

QUESTIONS OR COMMENTS?

Call toll free 1-844-374-0016 Monday through Friday 9AM - 5PM EST.

Principal Display Panel

NDC: 11788-023-12

Allergy

Diphenhydramine HCl

DYE-FREE SOFTGELS

*Compare to BENADRYL ® ALLERGY LIQUI-GELS ® Active Ingredient

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of BENADRYL ®.

Manufactured for:

AiPing Pharmaceutical, Inc.

Manufactured by:

Anshi Pharmaceutical (Zhongshan) Inc., P.R.China

diphen dye free

ALLERGY SOFTGEL
diphenhydramine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11788-023
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
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	yellow	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	AP023
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11788-023-12	1 in 1 CARTON	01/31/2015
1		12 in 1 BLISTER PACK; 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	01/31/2015	12/31/2019

Labeler - AiPing Pharmaceutical, Inc. (079674526)

Registrant - AiPing Pharmaceutical, Inc. (079674526)

Name	Address	ID/FEI	Business Operations
Establishment
Anshi Pharmaceutical (Zhongshan) Inc.		528101821	manufacture(11788-023)

Revised: 5/2021

Document Id: c32935f5-0659-fcea-e053-2995a90af030

Set id: 08c2eadb-69af-40f2-b427-ceaee393844d

Version: 7

Effective Time: 20210525

AiPing Pharmaceutical, Inc.