ASSORTED FRUIT PANNED CHEW- calcium carbonate tablet, chewable

Assorted Fruit panned chew by

Drug Labeling and Warnings

Assorted Fruit panned chew by is a Otc medication manufactured, distributed, or labeled by HEB, BestCo Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each chew)

Calcium Carbonate 750mg

PURPOSE

Purpose

Antacid

INDICATIONS & USAGE

Uses: Relieves

Heartburn Sour stomach Acid indigestion

Upset stomach due to these symptoms

WARNINGS

Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are now taking a prescription drug. Antacids may interact with certain prescription drugs.

Do not take more than 5 chews in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician.

When using this product constipation may occur.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions Adults and children 12 years and older chew and

swallow 1 to 2 chews every 2-4 hours as needed. Do not exceed

5 chews in 24-hours. Children under 12 years consult a doctor.

OTHER SAFETY INFORMATION

Other information

• Each chew contains: calcium 300 mg, magnesium 1mg
• Contains soy
• Contains FD&C yellow no. 5 (tartrazine) as a color additive
• Store between 20º to 25ºC (68º to 77ºF) in a dry place

INACTIVE INGREDIENT

Inactive Ingredients: Beeswax, carmine, carnauba wax, citric acid, corn starch, corn syrup, DL-alpha tocopherol, ethyl acetate, FD&C

blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 5 lake (tartrazine), FD&C yellow no. 6, FD&C yellow no. 6

aluminum lake, gum arabic, hydrogenated coconut oil, medium chain triglycerides, methyl paraben, modified corn starch, natural and

artificial flavors, pregelatinized corn starch, propylene glycol, propyl paraben, phosphoric acid, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, soybean oil, sucrose and titanium dioxide.

QUESTIONS

Questions: Or to report an adverse event call 1-800-245-2898 Monday - Friday, 9AM - 4PM EST

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ASSORTED FRUIT PANNED CHEW 
calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-063
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	750 mg

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)

Product Characteristics
Color	orange, yellow, pink	Score	score with uneven pieces
Shape	ROUND	Size	70mm
Flavor	ORANGE, LEMON, STRAWBERRY	Imprint Code	FC
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37808-063-20	120 in 1 BOTTLE; Type 0: Not a Combination Product	07/10/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	07/10/2016

Labeler - HEB (007924756)

Registrant - BestCo Inc. (002149136)

Establishment
Name	Address	ID/FEI	Business Operations
BestCo Inc.		002149136	manufacture(37808-063)