Flavor Chews: Package Insert and Label Information

FLAVOR CHEWS- calcium carbonate tablet, chewable
Walgreens

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredient (in each chew)

Calcium carbonate 750 mg

Purpose

Antacid

Uses:

Relieves

  • Heartburn
  • Sour stomach
  • Acid indigestion
  • Upset stomach due to these symptoms

Warnings

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

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

Ask a doctor or pharmacist before use if you are

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

When using this product constipation may occur

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

Keep out of reach of children

Directions

Adults and children 12 year sand 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.

Inactive ingredients

Beeswax, carmine, carnauba wax, citric acid, 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, sucrose, titanium dioxide. Soybean oil and corn starch are used as processing aids.

Other information

  • Each chew contains: calcium 300mg, magnesium 1mg
  • Contains soy
  • Store between 20 to 25 C (68 to 77 F) in a dry place

Questions?

Call 1-800-245-2898 Monday — Friday 9AM — 4PM EST

Walgreens Asst FC 36ct
(click image for full-size original)

FLAVOR CHEWS
calcium carbonate tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0011
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CARBONATE 750 mg
Inactive Ingredients
Ingredient Name Strength
WATER
Product Characteristics
Color yellow, pink, orange Score score with uneven pieces
Shape ROUND Size 70mm
Flavor ORANGE, LEMON, STRAWBERRY Imprint Code FC
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-0011-36 36 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC None
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part331 03/23/2015
Labeler — Walgreens (008965063)
Registrant — BestCo Inc. (002149136)
Establishment
Name Address ID/FEI Operations
BestCo Inc. 002149136 manufacture (0363-0011)

Revised: 02/2016 Walgreens

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