Allergy Relief Tablet, Coated
FDA Label NDC 83059-0021

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Shield Pharmaceuticals Corp for the product Allergy Relief (NDC 83059-0021). 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 liquid-filled capsule), purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, 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 Liquid-filled Capsule)

→ Purpose

→ uses

→ Warnings

→ Otc - Do Not Use

→ Otc - Ask Doctor

→ Otc - Ask Doctor/pharmacist

→ Otc - When Using

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel

Other

Drug Facts

Distributed by:
Shield Pharmaceuticals Corp.
Hauppauge, NY 11788

Active Ingredient (In Each Liquid-Filled Capsule)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

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
temporarily relieves these symptoms due to the common cold:
runny nose
sneezing

Warnings

Otc - Do Not Use

Do not use

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

Otc - Ask Doctor

Ask a doctor before use if you have

a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to an enlarged prostate gland
glaucoma

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before useif you are taking sedatives or tranquilizers

Otc - When Using

When using this product

marked drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives and tranquilizers may increase drowsiness
be careful 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 (1-800-222-1222) right away.

Directions

take every 4 to 6 hours, or as directed by a doctor
do not take more than 6 times in 24 hours

adults and children 12 years and over	1 to 2 tablets
children 6 to under 12 years	1 tablet
children under 6 years	do not use

Other Information

each tablet contains:calcium 25 mg
store between 20-25° C (68-77° F)
protect from moisture and light

Inactive Ingredients

each tablet contains: calcium 60 mg
store in a dry place at 15° – 30°C (59° – 86°F)
do not use if imprinted seal under cap is broken or missing

dibasic calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, FD&C red #3, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide

Questions Or Comments?

1-800-373-6981

Principal Display Panel

Allergy Relief