FDA.reportPublic FDA data

Allergy

Manufacturer
AiPing Pharmaceutical, Inc. | Anshi Pharmaceutical (Zhongshan) Inc.
Effective date
2020-10-13
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
legacy-cache
Hydrated at
2026-08-01 23:11:51

Label at a glance#

ProductAllergy Softgel
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and 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

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

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

Principal Display Panel

PACKAGE LABEL.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 freediphen dye free

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11788-02311788-023-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c32939a8-943d-31c6-e053-2995a90afdd9637588f4-1c42-ac42-e053-2991aa0a487c2021-05-25WarningsExact identifier
spl set id: 637588f4-1c42-ac42-e053-2991aa0a487c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.