Calmicid AC

Manufacturer
Melaleuca, Inc.
Effective date
2025-06-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:02:10

Label at a glance#

ProductCalmicid AC Acid Reducer
Active ingredientFAMOTIDINE
Label structure13 sections

Storage and handling

Other Information ■ read the directions and warnings before use ■ keep the carton. It contains important information. ■ store at 20°-25°C (68°-77°F) ■ protect from moisture and light

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Famotidine 20mg

OTC - PURPOSE SECTION

Purpose

Acid Reducer

INDICATIONS & USAGE SECTION

Uses

■ 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 SECTION

Warnings

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

OTC - DO NOT USE SECTION

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 SECTION

Ask a doctor before use if you have

■ had heartburn over 3 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

■ your heartburn continues or worsens

■ you need to take this product for more than 14 days

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

Other Information

■ read the directions and warnings before use

■ keep the carton. It contains important information.

■ store at 20°-25°C (68°-77°F)

■ protect from moisture and light

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Questions or comments?

1-800-282-3000

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Calmicid Bottle.jpgCalmicid Bottle.jpgCalmicid Box.jpgCalmicid Box.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1091399Calmicid AC 20 MG Oral TabletPSN1
310273famotidine 20 MG Oral TabletPSN1
1091399famotidine 20 MG Oral Tablet [Calmicid]SBD1
310273famotidine 20 MG Oral TabletSCD1
1091399Calmicid 20 MG Oral TabletSY1
1091399Calmicid AC 20 MG Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
FAMOTIDINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
396bde5c-c78e-2f8b-ab1f-2ee6ba32bcaeProduct name720260317
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
cf645750-2e70-f6e1-c05a-a52847def5ddProduct name920250312
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-411-01Calmicid ACAcid Reducer1 in 1 BOXTABLET, COATED11
54473-411-50Calmicid ACAcid Reducer50 in 1 BOTTLETABLET, COATED501

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54473-41154473-411-50, 54473-411-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calmicid AC Acid ReducerFAMOTIDINEMelaleuca, Inc.369ae213-cd23-57ba-e063-6394a90a87a62025-06-02WarningsExact identifier
ndc (package): 54473-411-01
ndc (package): 54473-411-50
ndc (product): 54473-411
ndc11 (package): 54473041101
ndc11 (package): 54473041150
spl id: 369ae213-cd24-57ba-e063-6394a90a87a6
spl set id: 369ae213-cd23-57ba-e063-6394a90a87a6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.