Indications and 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 foods and beverages
Rolaids ACID DEFENSE
- Manufacturer
- The Procter & Gamble Manufacturing Company
- Effective date
- 2026-10-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- daily-update
- Hydrated at
- 2026-10-06 02:02:22
Label at a glance#
ProductRolaids ACID DEFENSE
Active ingredientFAMOTIDINE
Label structure19 sections
Dosage and administration
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 tabelt with a glass of water 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
Contacts and useful links#
Label contents#
Full prescribing information#
Rolaids ACID DEFENSE
Drug Facts
Active ingredient (in each tablet)
Famotidine 20 mg
Purpose
Acid reducer
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 foods and beverages
Warnings
Allergy alert: Do not use if you are allergic to famotidine or other acid reducers
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.
- with other acid reducers
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
- kidney disease
Ask a doctor or pharnacist before use if you are
taking a prescription drug. Acid reducers may interact with certain prescription drugs.
Stop use and ask a doctor if
- your heartburn continues or worsens
- you need to take this product for mor than 14 days
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.
OVERDOSAGE SECTION
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
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 tabelt with a glass of water 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
Other information
- read the directions and warnings before use
- keep the carton. It contains important information.
- store at 20º - 25ºC (68º - 77ºF)
- protect from moisture
Inactive ingredients
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide
Questions or comments?
1-833-372-2729
SPL UNCLASSIFIED SECTION
TAMPER EVIDENT: DO NOT USE IF SEAL UNDER CAP IS MISSING OR DAMAGED
SPL UNCLASSIFIED SECTION
DIST. BY:
PROCTER & GAMBLE,
CINCINNATI, OH 45202
PRINCIPAL DISPLAY PANEL
MAXIMUM STRENGTH
Rolaids
ACID DEFENSE
FAMOTIDINE TABLETS, 20MG
ACID REDUCER
JUST 1 TABLET!
PREVENTS &
RELIEVES
HEARTBURN
DUE TO ACID INDIGESTION
25 TABLETS
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 396bde5c-c78e-2f8b-ab1f-2ee6ba32bcae | Product name | 7 | 20260317 |
| 1e73f975-1ce7-705e-2bcf-788b1b5e24ba | Product name | 5 | 20251124 |
| cf645750-2e70-f6e1-c05a-a52847def5dd | Product name | 9 | 20250312 |
| 4fdc761c-585e-054b-8ebe-86130a26e4c1 | Product name | 2 | 20221205 |
| fc2e1e31-353a-2c24-a4b4-fcf93bf7e38e | Product name | 1 | 20140508 |
Products#
Every source-derived product name is available through these pages.
- Rolaids ACID DEFENSE
- Famotitine
- FAMOTIDINE
- CROSCARMELLOSE SODIUM
- POLYVINYL ALCOHOL, UNSPECIFIED
- CARNAUBA WAX
- TALC
- SILICON DIOXIDE
- LACTOSE MONOHYDRATE
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 84126-367 | 84126-367-25 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FAMOTIDINE | 5QZO15J2Z8 | ACTIB |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| POLYVINYL ALCOHOL, UNSPECIFIED | 532B59J990 | IACT |
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| TALC | 7SEV7J4R1U | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 3 | 2026-03-30 | full-release | 2026-06-01 01:51:57 |
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077351-001 | FAMOTIDINE | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A077351-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077351-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077351-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077351-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077351-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077351-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077351-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077351-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077351-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077351-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077351-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077351-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077351-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077351-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077351-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077351-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077351-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077351-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077351-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A077351-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A077351-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A077351-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077351-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A077351-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A077351-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A077351-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A077351-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A077351-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A077351-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077351-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A077351-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A077351-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077351-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077351-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077351-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077351-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A077351-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A077351-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077351-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A077351-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | f41ea6bd6efb… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 4e3da807-1c29-8dd8-e063-6394a90ae5cb | 3bdbeabb-6b06-5468-e063-6394a90a03c9 | 2026-03-30 | Warnings | 3bdbeabb-6b06-5468-e063-6394a90a03c9 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.