Other
Drug Facts
Unishield Antacid Tablet, Chewable
FDA Label NDC 49314-1013
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Unishield for the product Unishield Antacid (NDC 49314-1013). 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, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor/pharmacist, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient (in each tablet)
Calcium Carbonate 420 mg
Otc - Purpose
Purpose
Antacid
Indications & Usage
Uses
For the relief of the following symptoms
■ acid indigestion
■ sour stomach
■ heartburn
■ upset stomach associated with these symptoms
Warnings
Warnings
Otc - Do Not Use
Do not use
■ the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a
physician or take more than 19 tablets in a 24 hour period.
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are
■ presently taking a prescription drug. Antacids may interact with certain prescription drugs.
Otc - Stop Use
Stop use and ask a doctor if
■ symptoms last more than 2 weeks
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 the reach of children.
Dosage & Administration
Directions
■ do not use more than directed
■ chew or crush tablets completely before swallowing
■ do not swallow tablets whole
Adults and children: (12 years and older) Chew 2 tablets every 2 or 3 hours as symptoms occur or as
directed by a physician. Do not exceed 19 tablets in 24 hours.
Children under 12 years: Do not give to children under 12 years of age.
Other Safety Information
Other information
■ phenylketonurics: may contain phenylalanine 1.5 mg per tablet
■ each tablet contains 168 mg of elemental calcium
■ store at room temperature 59-86°F (15-30°C) in a dry place
■ tamper-evident sealed packets
■ do not use any opened or torn packets
Inactive Ingredient
I nactive ingredients
aspartame*, croscarmellose sodium*, gum acacia*, magnesium stearate, maltodextrin, mineral oil*, mint flavor, sorbitol*, sucrose*
*may contain
Otc - Questions
Questions or comments? 1-800-480-5855
Package Label.Principal Display Panel
Unishield
Antacid
Calcium Carbonate 420 mg
100 Tablets/2 Tablets Per Packet
Calcium Rich Chewable Tablets
Pull To Open
• Relieves upset stomach, and indigestion
and heartburn
Chew or crush tablets completely before swallowing
Compare active ingredient to: TUMS®
Registered Trademark of McNeil Consumer Healthcare
Tamper Evident Unit Dose Packets
Unishield
Antacid
Calcium Carbonate 420 mg
100 Tablets/2 Tablets Per Packet
Calcium Rich Chewable Tablets
Pull To Open
• Relieves upset stomach, and indigestion
and heartburn
Chew or crush tablets completely before swallowing
Compare active ingredient to: TUMS®
Registered Trademark of McNeil Consumer Healthcare
Tamper Evident Unit Dose Packets
* Please review the disclaimer below.
