Sunmark Childrens Allergy Relief Dye-free Bubblegum Flavor

SPL v1

SPL

SPL Set ID 4609efc1-71d3-401e-b5f6-0caf48e8670f

Route

ORAL

Published

Effective Date 2014-10-27

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 Water Saccharin Sodium Sodium Benzoate Sorbitol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2013-08-08

Description

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCl 12.5 mg

Pdp

Sunmark

Compare to childrens benadyl active ingredient

Children's allergy relief dye-free

antihistamine

Relieves sneezing, runny nose, itchy, watery eyes, itchy throat

Diphenhydramine HCl

antihistamine

Bubblegum Flavor

4 fl oz (118mL)

Uses

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

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 under 12 years	1 to 2 tsp (5 mL to 10 mL)
adults and children 12 years and above	2 to 4 tsp (10 mL to 20 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^o - 77^oF

Inactive Ingredients

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

When Using This Product

avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
marked drowsiness may occur
excitability may occur especially in children
be careful when driving a motor vehicle or operating machinery

Ask Adoctor Before Use If You Have

glaucoma
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to an enlarged prostate gland

Active Ingredient (in Each 5 Ml Tsp)

Diphenhydramine HCl 12.5 mg

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

If Pregnant Or Breast Feeding, Ask A Health Professional Before Use.

Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

Structured Label Content

Pdp (PDP)

Sunmark

Compare to childrens benadyl active ingredient

Children's allergy relief dye-free

antihistamine

Relieves sneezing, runny nose, itchy, watery eyes, itchy throat

Diphenhydramine HCl

antihistamine

Bubblegum Flavor

4 fl oz (118mL)

Uses

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

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 under 12 years	1 to 2 tsp (5 mL to 10 mL)
adults and children 12 years and above	2 to 4 tsp (10 mL to 20 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^o - 77^oF

Inactive Ingredients (Inactive ingredients)

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

When Using This Product (When using this product)

avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
marked drowsiness may occur
excitability may occur especially in children
be careful when driving a motor vehicle or operating machinery

Ask Adoctor Before Use If You Have (Ask adoctor before use if you have)

glaucoma
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to an enlarged prostate gland

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

Diphenhydramine HCl 12.5 mg

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

taking sedatives or tranquilizers

If Pregnant Or Breast Feeding, Ask A Health Professional Before Use. (If pregnant or breast feeding, ask a health professional before use.)

Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

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": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "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)

{"PDP": "Sunmark Compare to childrens benadyl active ingredient Children's allergy relief dye-free antihistamine Relieves sneezing, runny nose, itchy, watery eyes, itchy throat Diphenhydramine HCl antihistamine Bubblegum Flavor 4 fl oz (118mL)", "Uses": "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", "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 under 12 years 1 to 2 tsp (5 mL to 10 mL) adults and children 12 years and above 2 to 4 tsp (10 mL to 20 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 o - 77 o F", "Inactive ingredients": "carboxymethylcellulose sodium, citric acid, flavors, glycerin, purified water, saccharin sodium, sodium benzoate, sorbitol", "When using this product": "avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness marked drowsiness may occur excitability may occur especially in children be careful when driving a motor vehicle or operating machinery", "Ask adoctor before use if you have": "glaucoma a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to an enlarged prostate gland", "Active ingredient (in each 5 mL tsp)": "Diphenhydramine HCl 12.5 mg", "Ask a doctor or pharmacist before use if you are": "taking sedatives or tranquilizers", "If pregnant or breast feeding, ask a health professional before use.": "Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:51.089715 · Updated: 2026-03-14T22:53:52.491278