PHARBETOL
- Manufacturer
- Direct_Rx
- Effective date
- 2019-07-30
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:17:46
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Acetaminophen 500mg
OTC - PURPOSE SECTION
Pain reliever/fever reducer
INDICATIONS & USAGE SECTION
Temporarily relieves minor aches and pains due to:
headache
backache
minor pain of arthritis
toothache
muscular aches
menstrual cramps
Temporarily reduces fever
WARNINGS SECTION
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
more than 8 tablets in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product
Do not use
With any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
if you are allergic to acetaminophen or any of the inactive ingredients in this product
Ask a doctor before use if you have
liver disease.
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin
Stop use and ask a doctor if:
Pain gets worse or lasts more than 10 days.
Fever gets worse or lasts more than 3 days.
New symptoms occur.
Redness or swelling is present.
These could be signs of a serious condition.
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
Overdose warning:
Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
do not take more than directed (see overdose warning).
Adult and Children 12 years and over: take 2 tablets, every 4 to 6 hours while symptoms last. Do not take more than 8 tablets in 24 hours. Do not take for more than 10 days unless directed by a doctor.
Children under 12 years: do not use adult extra strength product in children under 12 years of age; this will provide more than recommended dose (overdose) and may cause liver damage.
INACTIVE INGREDIENT SECTION
Povidone, Pregelatinized corn starch, sodium starch glycolate, stearic acid.
OTC - QUESTIONS SECTION
Adverse drug event call: (866) 562-2756
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
KEEP OUT OF REACH OF CHILDREN
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61919-861-50 | 2023-10-09 | C162847 | 48780-1 | f386c64a-3257-0266-e053-dadaa90a7c1a | PHARBETOL |
| 61919-861-50 | 2023-01-30 | C162847 | 48780-1 | f386c64a-3257-0266-e053-dadaa90a7c1a | PHARBETOL |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61919-861-50 | EA - Each | 61919-861 | 89b91d31-136f-4372-9c0f-10e702a9b103 | 1 | 2019-08-06 |
| 16103-376-06 | EA - Each | 16103-376 | b0ec28db-7535-413e-805f-e1416eeca918 | 1 | 2012-07-24 |
| 16103-376-08 | EA - Each | 16103-376 | b9284189-e1cd-4f69-88be-fb02466b57ca | 1 | 2012-07-24 |
| 16103-376-11 | EA - Each | 16103-376 | 7d6a6a6a-b98e-44d2-8664-e2351539d62b | 1 | 2012-07-24 |
Products#
Every source-derived product name is available through these pages.
- PHARBETOL
- ACETAMINOPHEN
- STEARIC ACID
- STARCH, CORN
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- POVIDONE K30
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61919-861 | 61919-861-50 |
| 16103-376 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
Source Document#
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 |
|---|---|---|---|---|---|---|
| Pharbetol | ACETAMINOPHEN | Pharbest Pharmaceuticals, Inc. | 04dbd98f-c74d-43b2-8bda-74f18be7cf6c | 2025-12-24 | Warnings | 16103-376 |
| 07d9fe22-c3cb-485c-e063-6294a90acdfc | 8eec0f6d-389d-0502-e053-2a95a90ae45d | 2023-10-16 | Warnings | 8eec0f6d-389d-0502-e053-2a95a90ae45d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
