FDA.reportPublic FDA data

Active ingredient (in each 5 mL)

Manufacturer
RARITAN PHARMACEUTICALS INC
Effective date
2026-07-17
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
daily-update
Hydrated at
2026-07-21 05:10:10

Label at a glance#

ProductADWE dye-free childrens allergy
Active ingredientDiphenhydramine hydrochloride
Label structure8 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

Dosage and administration

• find right dose on chart below • take every 4 to 6 hours, or as directed by a doctor • do not take more than 6 doses in 24 hours • mL = milliliter Age (yr) Dose (mL) children under 2 years do not use children 2 to 5 years do not use unless directed by a doctor children 6 to 11 years 5 mL to 10 mL Attention: use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.

Storage and handling

• each 5 mL contains : sodium 3 mg • store at room temperature) • protect from sunlight • see bottom panel for lot number and expiration date • contains low sodium

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl USP 12.5 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

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

OTC - ASK DOCTOR SECTION

Ask a doctor before use if the child has

  • a breathing problem such as chronic bronchitis
  • glaucoma

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this product

  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • find right dose on chart below
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
  • mL = milliliter

Age (yr)

Dose (mL)

children under 2 years

do not use

children 2 to 5 years

do not use unless directed by a doctor

children 6 to 11 years

5 mL to 10 mL

Attention: use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.

Other information

STORAGE AND HANDLING SECTION

  • each 5 mL contains: sodium 3 mg
  • store at room temperature)
  • protect from sunlight
  • see bottom panel for lot number and expiration date
  • contains low sodium

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68163-710-08

Compare to active ingredient in Children'sBenadryl® Dye-Free*

Children’s Allergy Relief

Antihistamine

Diphenhydramine HCl

For Relief Of:

  • Runny nose
  • sneezing
  • itchy, watery eyes
  • Itchy Throat or Nose

Natural Cherry Flavor

8 fl oz (236 mL)

Manufactured for:

Adwe Laboratories

1274th 49 Street

Brooklyn, NY 11219

*This product is not manufactured or distributed by Johnson & Johnson, owner of the registered trademark Children’s Benadryl® Dye –Free.

ADWE dye-free childrens allergy
ADWE dye-free childrens allergy

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68163-71068163-710-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
Diphenhydramine hydrochlorideTC2D6JAD40ACTIB
anhydrous citric acidXF417D3PSLIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
glycerinPDC6A3C0OXIACT
POTASSIUM CITRATEEE90ONI6FFIACT
water059QF0KO0RIACT
sodium benzoateOJ245FE5EUIACT
sorbitol506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52025-07-17full-release2026-06-01 01:07:38

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
ADWE dye-free childrens allergyDIPHENHYDRAMINE HYDROCHLORIDERARITAN PHARMACEUTICALS INCea3a51af-3025-497f-8cd7-e99391b0d06f2026-07-17WarningsExact identifier
ndc (package): 68163-710-08
ndc (product): 68163-710
ndc11 (package): 68163071008
spl id: f8611e9e-6741-46f4-ac4d-612b50799110
spl set id: ea3a51af-3025-497f-8cd7-e99391b0d06f

Reported adverse events (FAERS/openFDA)#

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