471 - Childrens Allergy Relief

SPL v3

SPL

SPL Set ID cb6df361-b8e5-4e2f-945f-c20159d76c4f

Route

ORAL

Published

Effective Date 2025-01-06

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (12.5 mg)

Inactive Ingredients

Anhydrous Citric Acid Glycerin Propylene Glycol Water Sodium Benzoate Sodium Chloride Trisodium Citrate Dihydrate Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-01-07

Description

Diphenhydramine HCl 12.5 mg in each 5ml

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCl 12.5 mg in each 5ml

Use(s)

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

Directions

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

Do Not Use

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

Other Information

each 5 ml contains: sodium 4 mg

store at 25°C (77°F); excursions permitted between 15-30°C (59°-86°F)

see end flap lot expiration date and lot number

Questions/comments

Call 1-888-952-0050 Monday Through Friday 9AM – 5PM EST.

Active Ingredient(s)

Diphenhydramine HCl 12.5 mg in each 5ml

Inactive Ingredients

anhydrous citric acid, flavor, glycerin, propylene glycol, purified water, sodium

benzoate, sodium chloride, sodium citrate dihydrate, sucralose, xanthan gum

Principal Display Panel

Allergy Relief

Children's Allergy Label

When Using This Product

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

Ask A Doctor Before Use If

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

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)

Ask A Doctor Or Pharmacist Before Use If

the child is taking sedatives or tranquilizers

Structured Label Content

Use(s)

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

Purpose

Antihistamine

Directions

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

Do Not Use (Do not use)

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

Other Information (Other information)

each 5 ml contains: sodium 4 mg

store at 25°C (77°F); excursions permitted between 15-30°C (59°-86°F)

see end flap lot expiration date and lot number

Questions/comments (Questions/Comments)

Call 1-888-952-0050 Monday Through Friday 9AM – 5PM EST.

Active Ingredient(s) (Active ingredient(s))

Diphenhydramine HCl 12.5 mg in each 5ml

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, flavor, glycerin, propylene glycol, purified water, sodium

benzoate, sodium chloride, sodium citrate dihydrate, sucralose, xanthan gum

Principal Display Panel

Allergy Relief

Children's Allergy Label

When Using This Product (When using this product)

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

Ask A Doctor Before Use If (Ask a doctor before use if)

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

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

Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)

the child is taking sedatives or tranquilizers

Advanced Ingredient Data

[{"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "12.5", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "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 CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRISODIUM CITRATE DIHYDRATE", "unii": "B22547B95K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use(s)": "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", "Purpose": "Antihistamine", "Directions": "do not take more than directed do not take more than 6 doses in 24 hours mL = milliliter only use the dosing cup provided find right dose on chart below take every 4 to 6 hours, or as directed by a doctor 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", "Do not use": "to make a child sleepy with any other product containing diphenhydramine, even one used on skin", "Other information": "each 5 ml contains: sodium 4 mg store at 25°C (77°F); excursions permitted between 15-30°C (59°-86°F) see end flap lot expiration date and lot number", "Questions/Comments": "Call 1-888-952-0050 Monday Through Friday 9AM – 5PM EST.", "Active ingredient(s)": "Diphenhydramine HCl 12.5 mg in each 5ml", "Inactive ingredients": "anhydrous citric acid, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, xanthan gum", "Principal Display Panel": "Allergy Relief Children's Allergy Label", "When using this product": "marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children", "Ask a doctor before use if": "a breathing problem such as chronic bronchitis glaucoma a sodium-restricted diet", "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)", "Ask a doctor or pharmacist before use if": "the child is taking sedatives or tranquilizers"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:33.376607 · Updated: 2026-03-14T23:07:34.278056