Max Allergy Kids

SPL v5

SPL

SPL Set ID 96c4ade8-67b1-41e5-8624-fb49090208af

Route

ORAL

Published

Effective Date 2025-03-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (12.5 mg)

Inactive Ingredients

Anhydrous Citric Acid Water Sodium Benzoate Sodium Citrate Saccharin Sodium Sorbitol Sucrose

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-11-15

Description

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCl 12.5 mg

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

Section 51945-4

Directions

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

Do Not Use

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

Other Information

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

Inactive Ingredients

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

Questions Or Comments?

Please Call 1(877) 225-6999

Manufactured for:

Akron Pharma, Inc,

Fairfield, NJ 07004

Manufactured in U.S.A

When Using This Product

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

Keep Out of Reach of Children.

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

Active Ingredient (in Each 5 Ml)

Diphenhydramine HCl 12.5 mg

Ask A Doctor Before Use If the Child Has

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

Ask A Doctor Or Pharmacist Before Use If the Child Is

taking sedatives or tranquilizers.

Structured Label Content

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

Section 51945-4 (51945-4)

Purpose

Antihistamine

Directions

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

Do Not Use (Do not use)

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

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

Please Call 1(877) 225-6999

Manufactured for:

Akron Pharma, Inc,

Fairfield, NJ 07004

Manufactured in U.S.A

When Using This Product (When using this product)

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

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Diphenhydramine HCl 12.5 mg

Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)

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

Ask A Doctor Or Pharmacist Before Use If the Child Is (Ask a doctor or pharmacist before use if the child is)

taking sedatives or tranquilizers.

Advanced Ingredient Data

[{"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCROSE", "unii": "C151H8M554", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "12.5", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"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", "Purpose": "Antihistamine", "Directions": "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", "Do not use": "with any other product containing diphenhydramine, even one used on skin to make a child sleepy", "Other information": "each 5 mL contains: sodium 8 mg store between 20°- 25°C (68°-77°F). Do not refrigerate protect from light", "Inactive ingredients": "anhydrous citric acid, bubble gum flavor, purified water, sodium benzoate, sodium citrate, saccharin sodium, sorbitol solution, sucrose.", "Questions or comments?": "Please Call 1(877) 225-6999 Manufactured for: Akron Pharma, Inc, Fairfield, NJ 07004 Manufactured in U.S.A", "When using this product": "marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitabillty may occur, especially in children", "Keep out of reach of children.": "In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.", "Active ingredient (in each 5 mL)": "Diphenhydramine HCl 12.5 mg", "Ask a doctor before use if the child has": "a breathing problem such as chronic bronchitis glaucoma a sodium restricted diet", "Ask a doctor or pharmacist before use if the child is": "taking sedatives or tranquilizers."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:22.747581 · Updated: 2026-03-14T23:13:15.147106