Quality Choice Dye Free Childrens Allergy Relief 549

SPL v1

SPL

SPL Set ID 302ca7b5-f65c-4187-bbd6-f482be6e63c1

Route

ORAL

Published

Effective Date 2024-03-18

Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (12.5 mg)

Inactive Ingredients

Carboxymethylcellulose Sodium Anhydrous Citric Acid Glycerin Saccharin Sodium Water Sodium Benzoate Sorbitol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-03-18

Description

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCl 12.5 mg

Use(s)

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose
itchy, watery eyes
sneezing
itching of the nose or throat

Warnings

Directions

take every 4 to 6 hours
do not take more than 6 doses in 24 hours

AGE(yr)	DOSE(mL or tsp)
children under 2 years	do not use
children under 6 years	ask a doctor
children 6 to 11 years	1 to 2 tsp (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 tsp contains: sodium 5 mg
dosing cup provided
store at 68°-77°F

Active Ingredient(s)

Diphenhydramine HCl 12.5 mg

Inactive Ingredients

carboxymethylcellulose sodium, citric acid, flavors, glycerin, purified water , saccharin sodium, sodium benzoate, sorbitol.

Principal Display Panel

NDC 83324-016-04

QC_® QUALITY CHOICE

*Compare to the Active Ingredient in Children's Benadryl^® Dye Free Allergy Liquid

Dye Free Children's Allergy Relief

Antihistamine

Diphenhydramine HCl

12.5 mg/5ml

Relieves: Sneezing, Runny Nose, Itchy, Watery Eyes & Itchy Throat

CHERRY FLAVOR

4FL OZ(120 mL)

When Using This Product

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

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If Child Has

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

Ask A Doctor Or Pharmacist Before Use If the Child Is

taking sedatives or tranquilizers.

Structured Label Content

Use(s) (USE(S))

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose
itchy, watery eyes
sneezing
itching of the nose or throat

Purpose (PURPOSE)

Antihistamine

Warnings (WARNINGS)

Directions (DIRECTIONS)

take every 4 to 6 hours
do not take more than 6 doses in 24 hours

AGE(yr)	DOSE(mL or tsp)
children under 2 years	do not use
children under 6 years	ask a doctor
children 6 to 11 years	1 to 2 tsp (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 tsp contains: sodium 5 mg
dosing cup provided
store at 68°-77°F

Active Ingredient(s) (ACTIVE INGREDIENT(S))

Diphenhydramine HCl 12.5 mg

Inactive Ingredients (INACTIVE INGREDIENTS)

carboxymethylcellulose sodium, citric acid, flavors, glycerin, purified water , saccharin sodium, sodium benzoate, sorbitol.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 83324-016-04

QC_® QUALITY CHOICE

*Compare to the Active Ingredient in Children's Benadryl^® Dye Free Allergy Liquid

Dye Free Children's Allergy Relief

Antihistamine

Diphenhydramine HCl

12.5 mg/5ml

Relieves: Sneezing, Runny Nose, Itchy, Watery Eyes & Itchy Throat

CHERRY FLAVOR

4FL OZ(120 mL)

When Using This Product (WHEN USING THIS PRODUCT)

alcohol, sedatives and tranquilizers may increase drowsiness
marked drowsiness may occur
excitability 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 right away.

Ask A Doctor Before Use If Child Has (ASK A DOCTOR BEFORE USE IF CHILD HAS)

glaucoma
a breathing problem such as emphysema or chronic bronchitis
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": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "12.5", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "CARBOXYMETHYLCELLULOSE SODIUM", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "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": "SORBITOL", "unii": "506T60A25R", "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 itchy, watery eyes sneezing itching of the nose or throat", "PURPOSE": "Antihistamine", "WARNINGS": ".", "DIRECTIONS": "take every 4 to 6 hours do not take more than 6 doses in 24 hours AGE(yr) DOSE(mL or tsp) children under 2 years do not use children under 6 years ask a doctor children 6 to 11 years 1 to 2 tsp (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 tsp contains : sodium 5 mg dosing cup provided store at 68°-77°F", "ACTIVE INGREDIENT(S)": "Diphenhydramine HCl 12.5 mg", "INACTIVE INGREDIENTS": "carboxymethylcellulose sodium, citric acid, flavors, glycerin, purified water , saccharin sodium, sodium benzoate, sorbitol.", "PRINCIPAL DISPLAY PANEL": "NDC 83324-016-04 QC ® QUALITY CHOICE *Compare to the Active Ingredient in Children's Benadryl ® Dye Free Allergy Liquid Dye Free Children's Allergy Relief Antihistamine Diphenhydramine HCl 12.5 mg/5ml Relieves : Sneezing, Runny Nose, Itchy, Watery Eyes & Itchy Throat CHERRY FLAVOR 4FL OZ(120 mL) ", "WHEN USING THIS PRODUCT": "alcohol, sedatives and tranquilizers may increase drowsiness marked drowsiness may occur excitability may occur, especially in children", "KEEP OUT OF REACH OF CHILDREN.": "In case of overdose, get medical help or contact a Poison Control Center right away.", "ASK A DOCTOR BEFORE USE IF CHILD HAS": "glaucoma a breathing problem such as emphysema or chronic bronchitis 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: 2026-02-15T12:02:52.834811 · Updated: 2026-03-14T23:02:40.652524