Kids-eeze
FDA Label NDC 61941-1005

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Prophase Labs, Inc. for the product Kids-eeze (NDC 61941-1005). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each soft chew), purpose, uses, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredient (in Each Soft Chew)

→ Purpose

→ Uses

→ Do Not Use

→ Ask A Doctor Before Use If You Have

→ Otc - Ask Doctor/pharmacist

→ When Using This Product

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Otc - Questions

→ Principal Display Panel - 12.5 Mg Package

Other

Drug Facts

Active Ingredient (In Each Soft Chew)

Diphenhydramine Hydrochloride 12.5mg

Purpose

Antihistamine

Uses

For the temporary relief of

runny nose
sneezing
itching of the nose or throat
itchy, watery eyes due to hay fever or other upper respiratory allergies

Do Not Use

with any other product containing diphenhydramine, even one used on the skin

Ask A Doctor Before Use If You Have

a breathing problem such as emphysema or chronic bronchitis
glaucoma
difficulty in urination due to enlargement of the prostate gland

Otc - Ask Doctor/Pharmacist

Ask a doctor before use if you are taking sedatives or tranquilizers.

When Using This Product

marked drowsiness may occur
alcohol, sedatives and tranquilizers may increase the drowsiness effect
avoid alcoholic beverages while taking this product
use caution when driving a motor vehicle or operating machinery
excitability may occur, especially in children

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - 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.

Directions

Chew and swallow as directed below

Do not take more than 6 doses in 24 hours

adults and children 12 years and over	2 to 4 chews every 4 to 6 hours
children 6 years to under 12 years	1 to 2 chews every 4 to 6 hours
children under 6 years of age	ask a doctor

Other Information

each soft chew contains 6 mg sodium
tamper evident: do not use if inner blister pack is torn or open
store at controlled room temperature 15-30°C (59-86°F)

Inactive Ingredients

ammonium glycyrrhizinate, cellulose, croscarmellose sodium, D&C red #27 lake, ethylcellulose, FD&C blue #1 lake, fructose, flavors, hydroxypropylcellulose, lecithin, malic acid, microcrystalline cellulose, sodium chloride, sucralose, sugar, vegetable oil, xylitol