HARRIS TEETER ACID REDUCER COMPLETE

Manufacturer
Harris Teeter, LLC
Effective date
2021-11-15
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:27:47

Label at a glance#

ProductHARRIS TEETER ACID REDUCER COMPLETE
Active ingredientFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE
Label structure9 sections

Dosage and administration

• adults and children 12 years and over: • do not swallow tablet whole: chew completely • to relieve symptoms, chew 1 tablet before swallowing • do not use more than 2 chewable tablets in 24 hours • children under 12 years: ask a doctor

Storage and handling

• each tablet contains: calcium 330 mg; magnesium 80 mg • Phenylketonurics: Contains Phenylalanine 2 mg per tablet • read the directions and warnings before use • read the bottle. It contains important information. • store at 20-25°C (68-77°F) • protect from moisture

Label contents#

Full prescribing information#

Active ingredients (in each chewable tablet)

OTC - ACTIVE INGREDIENT SECTION

Famotidine 10 mg

Calcium carbonate 800 mg

Magnesium hydroxide 165 mg

Purposes

OTC - PURPOSE SECTION

Acid reducer

Antacid

Use

INDICATIONS & USAGE SECTION

relieves heartburn associated with acid indigestion and sour stomach

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • 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.
  • with other acid reducers

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • 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
  • kidney disease

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking a prescription drug. Antacids and acid reducers may interact with certain prescription drugs.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and over:
  • do not swallow tablet whole: chew completely
  • to relieve symptoms, chew 1 tablet before swallowing
  • do not use more than 2 chewable tablets in 24 hours
  • children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 330 mg; magnesium 80 mg
  • Phenylketonurics: Contains Phenylalanine 2 mg per tablet
  • read the directions and warnings before use
  • read the bottle. It contains important information.
  • store at 20-25°C (68-77°F)
  • protect from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous lactose, artificial berry flavor, aspartame, D&C red no. 7 calcium lake, dextrates, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, glyceryl monostearate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyacrylate dispersion, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, talc

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

See New Warnings

Compare to active ingredients in Pepcid Complete®

ACID REDUCER COMPLETE

Famotidine 10mg/Calcium Carbonate 800mg

Magnesium Hydroxide 165mg Tablets (Chewable)

Acid Reducer + Antacid

Dual Action

Just One Tablet!

Relieves Heartburn Due to Acid Indigestion

Berry Flavor

Actual Size

25 CHEWABLE TABLETS

321-ht-acid-reducer-complete.jpg
321-ht-acid-reducer-complete.jpg

FDA-Initiated Inactive NDC Indexing#

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69256-00469256-004-63

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDECALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-06

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-0684e616aacf4f…
2026-08-18 06:07:402026-07A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-063f01610625f2…
2019-09-15 20:21 UTC2019-09A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-063f0d92c62455…
2023-05-13 08:27 UTC2023-05A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-06053a50430f4f…
2023-01-26 05:58 UTC2023-01A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-06f41ea6bd6efb…

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
4f8cfc28-b022-4293-81a5-62adbc18f1413297fc6a-f440-4bbb-aae2-5d08e44d97ce2022-07-13WarningsExact identifier
spl set id: 3297fc6a-f440-4bbb-aae2-5d08e44d97ce

Reported adverse events (FAERS/openFDA)#

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