FDA Label for Antacid

View Indications, Usage & Precautions

Antacid Product Label

The following document was submitted to the FDA by the labeler of this product Advance Pharmaceutical Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



(in each tablet)

Calcium Carbonate 10 gr (648 mg)


Purpose



Antacid


Uses



relieves

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

Warnings



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

Stop use and ask a doctor if symptoms last more than 2 weeks.

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


Keep Out Of Reach Of Children.



In case of overdose, get medical help or contact a Poison Control Center right away.


Directions



  • take one to four tablets daily.
  • do not take more than 4 tablets in 24 hours
  • do not use the maximum dosage for more than 2 weeks

Other Information



  • each tablet contains: calcium 260 mg
  • store at room temperature 15-30 °C (59-86 °F)
  • For 1000 Count: This is a bulk package. Dispense contents in a tight, light-resistant container with a child-resistant closure as defined in the USP.

Inactive Ingredients



Croscarmellose sodium, magnesium stearate, maltodextrin, microcrystalline cellulose, stearic acid


Questions Or Comments



Call 631-981-4600, Monday-Friday, 8.30 am – 4.30 pm ET

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Manufactured by: Advance Pharmaceutical Inc. Holtsville, NY 11742


Package Label.Principal Display Panel



Calcium Carbonate 10 gr

Antacid tablets

NDC: 17714-025-01 – 100 COUNT

NDC: 17714-025-10 – 1000 COUNT (THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN)


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