MAX Allergy Kids

Manufacturer
Akron Pharma Inc.
Effective date
2026-09-01
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
daily-update
Hydrated at
2026-09-03 03:01:53

Label at a glance#

ProductMAX ALLERGY KIDS
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

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

Storage and handling

each 5 mL contains: sodium 8 mg store between 20°- 25°C (68°-77°F). Do not refrigerate protect from light

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 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:
    • sneezing
    • runny nose
    • itchy, watery eyes
    • itchy of the nose or throat

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if the child has

OTC - ASK DOCTOR SECTION

  • a breathing problem such as chronic bronchitis
  • glaucoma
  • a sodium restricted diet

Ask a doctor or pharmacist before use if the child is

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

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

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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

  • each 5 mL contains:sodium 8 mg
  • store between 20°- 25°C (68°-77°F). Do not refrigerate
  • protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, bubble gum flavor, purified water, sodium benzoate, sodium citrate, saccharin sodium, sorbitol solution, sucrose.

Questions or comments?

OTC - QUESTIONS SECTION

Please Call 1(877) 225-6999

Manufactured for:
Akron Pharma, Inc,
Fairfield, NJ 07004

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1122334455

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130371399002341GTIN-13: 0371399002341
EAN-13: 0371399002341
GTIN-12: 371399002341
UPC-A: 371399002341
GTIN storage (14 digits): 00371399002341
4 OZ LABEL.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71399-0023-42025-03-10C16284748780-12cef2736-91c7-d83d-e063-dadaa90ab31fMAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-42025-03-10C16284748780-12cef2736-91c7-d83d-e063-dadaa90ab31fMAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-42025-03-10C16284748780-12cef2736-91c7-d83d-e063-dadaa90ab31fMAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-62025-03-10C16284748780-12cef2736-91c7-d83d-e063-dadaa90ab31fMAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-62025-03-10C16284748780-12cef2736-91c7-d83d-e063-dadaa90ab31fMAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-62025-03-10C16284748780-12cef2736-91c7-d83d-e063-dadaa90ab31fMAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-82025-03-10C16284748780-12cef2736-91c7-d83d-e063-dadaa90ab31fMAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-82025-03-10C16284748780-12cef2736-91c7-d83d-e063-dadaa90ab31fMAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-82025-03-10C16284748780-12cef2736-91c7-d83d-e063-dadaa90ab31fMAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-42025-01-30C16284748780-12cef2736-91c7-d83d-e063-dadaa90ab31fMAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-42025-01-30C16284748780-12cef2736-91c7-d83d-e063-dadaa90ab31fMAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-42025-01-30C16284748780-12cef2736-91c7-d83d-e063-dadaa90ab31fMAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-62025-01-30C16284748780-12cef2736-91c7-d83d-e063-dadaa90ab31fMAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-62025-01-30C16284748780-12cef2736-91c7-d83d-e063-dadaa90ab31fMAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-62025-01-30C16284748780-12cef2736-91c7-d83d-e063-dadaa90ab31fMAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-82025-01-30C16284748780-12cef2736-91c7-d83d-e063-dadaa90ab31fMAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-82025-01-30C16284748780-12cef2736-91c7-d83d-e063-dadaa90ab31fMAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-82025-01-30C16284748780-12cef2736-91c7-d83d-e063-dadaa90ab31fMAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-0023-4ML - Milliliter71399-0023232720a1-d277-4d6a-a8c5-7701426738e612024-08-12
71399-0023-6ML - Milliliter71399-00233429ad22-cb2f-4777-ad75-bd0189be58f712024-08-12
71399-0023-8ML - Milliliter71399-002387e2cddc-3c9a-4e7c-8059-082b6eacd04312024-04-05

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
71399-002371399-0023-4, 71399-0023-8, 71399-0023-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52025-10-27full-release2026-06-01 01:41:00
42025-06-24full-release2026-06-01 01:03:50

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
MAX ALLERGY KIDSDIPHENHYDRAMINE HCLAkron Pharma Inc.96c4ade8-67b1-41e5-8624-fb49090208af2026-09-01WarningsExact identifier
ndc (package): 71399-0023-6
ndc (package): 71399-0023-4
ndc (package): 71399-0023-8
ndc (product): 71399-0023
ndc11 (package): 71399002304
ndc11 (package): 71399002306
ndc11 (package): 71399002308
spl id: 5a655a7d-cae6-93d8-e063-6394a90a1cca
spl set id: 96c4ade8-67b1-41e5-8624-fb49090208af

Reported adverse events (FAERS/openFDA)#

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