CALMICID AC ACID REDUCER- loratadine tablet, film coated

Calmicid AC by

Drug Labeling and Warnings

Calmicid AC by is a Otc medication manufactured, distributed, or labeled by Praxis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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
  

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
  

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
  

PREGNANCY OR BREAST FEEDING

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

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 relievesymptoms, swallow 1 tablet with a glass of water. Do not chew.
  • to preventsymptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutesbeforeeating food or drinking beverages that cause heartburn
  • do not use more than 2 tablets in 24 hours
• children under 12 years: ask a doctor
  

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Famotidine 20 mg

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

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

QUESTIONS

Questions or comments?
1-800-282-3000

BOXED WARNING

(What is this?)

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.
  

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CALMICID AC  ACID REDUCER
loratadine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59368-285
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8)	FAMOTIDINE	20 mg

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL (UNII: 532B59J990)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white (white)	Score	no score
Shape	ROUND (biconvex)	Size	8mm
Flavor		Imprint Code	L194
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59368-285-01	1 in 1 CARTON	01/01/2018
1		50 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090283	01/20/2011

Labeler - Praxis, LLC (016329513)

Establishment
Name	Address	ID/FEI	Business Operations
Praxis, LLC		016329513	manufacture(59368-285) , label(59368-285) , pack(59368-285)