Calmicid Ac
FDA Label NDC 54473-203

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Melaleuca, Inc. for the product Calmicid Ac (NDC 54473-203). 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 otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Purpose

Purpose
Acid reducer

Indications & Usage

Use

  • relieves heartburn associated with acid indigestion and sour stomach
  • prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages

Warnings

Warnings
Allergy alert: Do not use if you are allergic to famotidine or other acid reducers

Otc - Do Not Use

Do not use

  • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
  • if you have kidney disease, except under the advice and supervision of a doctor
  • with other acid reducers

Otc - Ask Doctor

Ask a doctor before use if you have

  • had heartburn over three months. This may be a sign of a more serious condition.
  • heartburn with lightheadedness, sweating, or dizziness
  • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
  • frequent chest pain
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain

Otc - Stop Use

Stop use and ask a doctor if

  • your heartburn continues or worsens
  • you need to take this product for more than 14 days

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

Directions

  • adults and children 12 years and over:
      • to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
      • to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn
      • do not use more than 2 tablets in 24 hours
      • children under 12 years: ask a doctor

Storage And Handling

Other information

  • store at 20°-25°C (68°-77°F)
  • protect from moisture and light

Inactive Ingredient

Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, lactose (monohydrrate), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide

Otc - Questions

Questions or comments?
1-800-282-3000

Boxed Warning

DO NOT USE IF PRINTED FOIL UNDER CAP IS BROKEN OR MISSING

General Precautions

Other information

  • read the directions and warnings before use
  • keep the carton, it contains important information.

Package Label.Principal Display Panel

Image Of Box (Calmicidacbox)

Image Of Box (Calmicidacbox)

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