Indications and uses
Temporarily relieves minor aches and pains due to the common cold headache backache minor pain of arthritis toothache muscular aches menstrual cramps Temporarily reduces fever
Pharbetol
- Manufacturer
- Coupler Enterprises
- Effective date
- 2021-02-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 23:38:31
Label at a glance#
ProductPharbetol Regular strength
Active ingredientACETAMINOPHEN
Label structure9 sections
Dosage and administration
do not take more than directed (see overdose warning). Adults and children 12 years and over Take 2 tablets every 4 to 6 while symptoms last. Do not take more than 12 tablets in 24 hours. Children 6 to under 12 years Take 1 tablet every 4 to 6 while symptoms last. Do not take more than 5 tablets in 24 hours. Children under 6 years Do not use adult regular strength products in childern under 6 ...
Storage and handling
Tamper Evident: do not use if imprinted safety seal under cap is broken or missing store between 20-25°C (68-77°F) use by expiration date on package
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (per tablet)
Acetaminophen 325mg
Purpose
Pain reliever/Fever reducer
Uses
- Temporarily relieves minor aches and pains due to
- the common cold
- headache
- backache
- minor pain of arthritis
- toothache
- muscular aches
- menstrual cramps
- Temporarily reduces fever
Warnings
Liver warning:This product contains acetaminophen. Severe liver damage may occur if
- Adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
- Child takes more than 5 doses in 24 hours
- Taken with other drugs containing acetaminophen
- Adult has 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 in adults and children
- Pain gets worse or lasts more than 5 days in children under 12 years
- Fever gets worse or lasts more than 3 days
- New symptoms occur
- Redness or swelling is present
These could be sign of a serious condition.
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of the reach of children.
Overdose warning:
Taking more than the recommended dose (overdose) may cause liver damage. In the case of accidental overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not take more than directed (see overdose warning).
| Adults and children 12 years and over
| Take 2 tablets every 4 to 6 while symptoms last.
Do not take more than 12 tablets in 24 hours. |
| Children 6 to under 12 years
| Take 1 tablet every 4 to 6 while symptoms last.
Do not take more than 5 tablets in 24 hours. |
| Children under 6 years
| Do not use adult regular strength products in childern under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.
|
Other information
- Tamper Evident: do not use if imprinted safety seal under cap is broken or missing
- store between 20-25°C (68-77°F)
- use by expiration date on package
Inactive ingredients:
Povidone, pregelatinized starch, sodium starch glycolate, stearic acid.
Questions?
Adverse drug event call: (866) 562-2756
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 313782 | acetaminophen 325 MG Oral Tablet | PSN | 3 |
| 1298830 | Pharbetol Regular Strength 325 MG Oral Tablet | PSN | 3 |
| 1298830 | acetaminophen 325 MG Oral Tablet [Pharbetol] | SBD | 3 |
| 313782 | acetaminophen 325 MG Oral Tablet | SCD | 3 |
| 313782 | APAP 325 MG Oral Tablet | SY | 3 |
| 1298830 | APAP 325 MG Oral Tablet [Pharbetol] | SY | 3 |
| 1298830 | Pharbetol 325 MG Oral Tablet | SY | 3 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67046-023-30 | PharbetolRegular strength | 30 in 1 BLISTER PACK | TABLET | 30 | 3 | |
| 67046-023-60 | PharbetolRegular strength | 60 in 1 BLISTER PACK | TABLET | 60 | 3 | |
| 67046-023-62 | PharbetolRegular strength | 60 in 1 BLISTER PACK | TABLET | 60 | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 16103-353-07 | EA - Each | 16103-353 | be19f1cb-5a83-4ab8-a81c-dbc7b6c366b3 | 1 | 2013-05-02 |
| 16103-353-08 | EA - Each | 16103-353 | d0efd342-8f78-4b8b-b2ab-963c13f461bf | 1 | 2013-05-02 |
| 16103-353-11 | EA - Each | 16103-353 | 239e09b4-a5bc-4312-a3cc-d82250536ba3 | 1 | 2013-05-02 |
Products#
Every source-derived product name is available through these pages.
- Pharbetol Regular strength
- Acetaminophen
- POVIDONE
- STARCH, CORN
- SODIUM STARCH GLYCOLATE TYPE A CORN
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 67046-023 | 67046-023-30, 67046-023-60, 67046-023-62 |
| 16103-353 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POVIDONE | FZ989GH94E | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| SODIUM STARCH GLYCOLATE TYPE A CORN | AG9B65PV6B | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
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 Regular strength | ACETAMINOPHEN | Pharbest Pharmaceuticals, Inc. | e0a39957-d918-4125-88f9-0e550b976fa1 | 2025-12-24 | Warnings | 16103-353 |
| bc1cdbdb-b3ec-2397-e053-2995a90a9c81 | 57e5fc8c-8d69-a36d-e053-2a91aa0af949 | 2021-02-24 | Warnings | bc1cdbdb-b3ec-2397-e053-2995a90a9c81 57e5fc8c-8d69-a36d-e053-2a91aa0af949 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.