FIRST AID ONLY ANTACID- calcium carbonate tablet, chewable

First Aid Only Antacid by

Drug Labeling and Warnings

First Aid Only Antacid by is a Otc medication manufactured, distributed, or labeled by Acme United Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Calcium Carbonate 420 mg

Purpose

Antacid

Uses

For the relief of the following symptoms associated with

• acid indigestion
• sour stomach
• heartburn
• upset stomach associated with these symptoms

Warnings

Ask a doctor or phamacist before use if you are

• taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

• do not take more than 19 tablets in 24 hours
• do not use the maximum dosage for more than 2 weeks except under the advise and supervision of a physician
• do not exceed recommended dosage

Stop using this product and ask a doctor if

• symptoms last more than 2 weeks

Keep out of the reach of children.

As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

If you are pregnant or breast feeding,

ask a health profdessional before use.

Directions

• do not use more than directed

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 take more than 19 tablets in 24 hours.

Children under 12 years: Do not give to children under 12 years of age.

Other information

• Phenylketonurics: contains 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 ingredients

aspartame*, croscarmellose sodium*, gum acacia*, magnesium stearate, maltodextrin, mineral oil*, mint flavor, sorbitol*, sucrose*

*may contain

Questions or comments?

Call 1-800-835-2263

PRINCIPAL DISPLAY PANEL

First Aid Only Antacid Label

INGREDIENTS AND APPEARANCE

FIRST AID ONLY ANTACID 
calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0924-0287(NDC:47682-201)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D)	CALCIUM CARBONATE	420 mg

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME (UNII: Z0H242BBR1)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MINERAL OIL (UNII: T5L8T28FGP)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	white (white)	Score	no score
Shape	ROUND (ROUND)	Size	11mm
Flavor		Imprint Code	AZ;036
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0924-0287-01	20 in 1 BOX, UNIT-DOSE	03/28/2018
1		2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	06/15/2014

Labeler - Acme United Corporation (001180207)

Registrant - Acme United Corporation (001180207)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		045924339	relabel(0924-0287) , repack(0924-0287)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		080119599	relabel(0924-0287) , repack(0924-0287)