Sunmark Children Allergy Relief Dye Free Cherry

SPL v6

SPL

SPL Set ID 5c6c1809-4c6f-4e8f-a5ae-9796e821d400

Route

ORAL

Published

Effective Date 2023-11-01

Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (12.5 mg)

Inactive Ingredients

Carboxymethylcellulose Sodium, Unspecified Form Anhydrous Citric Acid Glycerin Water Sodium Benzoate Sorbitol Saccharin Sodium Anhydrous

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-04-22

Description

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

How Supplied

Product: 50090-6163 NDC: 50090-6163-0 118 mL in a BOTTLE / 1 in a CARTON

Medication Information

Purpose

Antihistamine

How Supplied

Product: 50090-6163

NDC: 50090-6163-0 118 mL in a BOTTLE / 1 in a CARTON

Description

Diphenhydramine HCl 12.5 mg

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

Warnings

Directions

find right dose on chart below

mL=milliliter
measure only with dosing cup provided
do not use dosing cup with other products
take every 4 to 6 hours, or as directed by a doctor
do not take more than 6 doses in 24 hours

AGE(yr)	DOSE(mL)
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 5 mg
dosing cup provided
store between 20 - 25^oC (68^o- 77^oF)

Inactive Ingredients

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

Questions Or Comments?

Call 833-358-6431 Monday to Friday 9:00 am to 7:00 pm EST

When Using This Product

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

(1-800-222-1222).

Active Ingredient(in Each 5 Ml)

Diphenhydramine HCl 12.5 mg

Children Allergy Relief Dye Free

Ask A Doctor Before Use If the Child Has

glaucoma
a breathing problem such as chronic bronchitis

Ask A Doctor Or Pharmacist Before Use If the Child Is

taking sedatives or tranquilizers

Structured Label Content

Uses (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 (PURPOSE)

Antihistamine

Warnings (WARNINGS)

Directions (DIRECTIONS)

find right dose on chart below

mL=milliliter
measure only with dosing cup provided
do not use dosing cup with other products
take every 4 to 6 hours, or as directed by a doctor
do not take more than 6 doses in 24 hours

AGE(yr)	DOSE(mL)
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

How Supplied (HOW SUPPLIED)

Product: 50090-6163

NDC: 50090-6163-0 118 mL in a BOTTLE / 1 in a CARTON

Other Information (OTHER INFORMATION)

each 5 mL contains: sodium 5 mg
dosing cup provided
store between 20 - 25^oC (68^o- 77^oF)

Inactive Ingredients (INACTIVE INGREDIENTS)

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

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Call 833-358-6431 Monday to Friday 9:00 am to 7:00 pm EST

When Using This Product (WHEN USING THIS PRODUCT)

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

(1-800-222-1222).

Active Ingredient(in Each 5 Ml) (ACTIVE INGREDIENT(in each 5 mL))

Diphenhydramine HCl 12.5 mg

Children Allergy Relief Dye Free (CHILDREN ALLERGY RELIEF DYE FREE)

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

glaucoma
a breathing problem such as chronic bronchitis

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, UNSPECIFIED FORM", "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": "sodium benzoate", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "sorbitol", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM ANHYDROUS", "unii": "I4807BK602", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "WARNINGS": ".", "DIRECTIONS": "find right dose on chart below mL=milliliter measure only with dosing cup provided do not use dosing cup with other products take every 4 to 6 hours, or as directed by a doctor do not take more than 6 doses in 24 hours AGE(yr) DOSE(mL) 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", "HOW SUPPLIED": "Product: 50090-6163 NDC: 50090-6163-0 118 mL in a BOTTLE / 1 in a CARTON", "OTHER INFORMATION": "each 5 mL contains: sodium 5 mg dosing cup provided store between 20 - 25 o C (68 o - 77 o F)", "INACTIVE INGREDIENTS": "carboxymethylcellulose sodium, citric acid, flavors, glycerin, purified water, saccharin sodium, sodium benzoate, sorbitol. ", "QUESTIONS OR COMMENTS?": "Call 833-358-6431 Monday to Friday 9:00 am to 7:00 pm EST", "WHEN USING THIS PRODUCT": "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 (1-800-222-1222).", "ACTIVE INGREDIENT(in each 5 mL)": "Diphenhydramine HCl 12.5 mg", "ASK A DOCTOR BEFORE USE IF THE CHILD HAS": "glaucoma a breathing problem such as chronic bronchitis", "ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS": "taking sedatives or tranquilizers"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:11.577270 · Updated: 2026-03-14T23:01:36.166619