Allergy
FDA Label NDC 45014-140

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Accudial Pharmaceutical, Inc. for the product Allergy (NDC 45014-140). 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 active ingredient (in each 5 ml)5ml = one teaspoon, purpose, uses, do not use, ask a doctor before use if the child has, when using this product, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient (in Each 5 Ml)5ml = One Teaspoon

→ Purpose

→ Uses

→ Do Not Use

→ Ask A Doctor Before Use If The Child Has

→ When Using This Product

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Principal Display Panel - 118 Ml Carton

Active Ingredient (In Each 5 Ml)5Ml = One Teaspoon

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Uses

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

Do Not Use

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

Ask A Doctor Before Use If The Child Has

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

When Using This Product

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

Directions

take every 4 to 6 hours
do not take more than 6 doses in 24 hours
to find right dose, use rotating bottle label to dose by weight; otherwise, use chart below to dose by age
specifically designed for use with enclosed dosing spoon. Use only enclosed dosing spoon to dose this product. Do not use any other dosing device

children under 2 years	do not use
children 2 to 5 years	do not use unless directed by a doctor
children 6 to under 12 years	5 mL to 10 mL (1 to 2 teaspoonfuls)

Other Information

each teaspoon contains:

sodium 3 mg
store between 20°-25°C (68°-79°F). Protect from light. Store in outer carton until contents used.

Inactive Ingredients

artificial flavor, citric acid, D&C red no. 33, FD&C red no. 40, glycerin, polysorbate 20, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol.