CETAFEN
- Manufacturer
- A-S Medication Solutions
- Effective date
- 2018-08-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:52:35
Label at a glance#
ProductCETAFEN
Active ingredientACETAMINOPHEN
Label structure14 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient (in each tablet): Acetaminophen 325mg
INDICATIONS & USAGE SECTION
Uses:
Temporarily relieves minor aches and pains due to:
- headache
- muscular aches
- backache
- minor arthritis pain
- the common cold
- toothache
- menstrual cramps
Temporarily reduces fever
WARNINGS SECTION
Warnings:
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
OTC - DO NOT USE SECTION
Do not use with any other drug containing acetaminophen (prescription or non-prescription)
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if:
- you are taking the blood thinning drug warfarin
- you do not know if other drugs you are taking contain acetaminophen
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have liver disease
OTC - STOP USE SECTION
Stop use and ask a doctor if:
- new symptom occur
- redness or swelling is present
- fever worsens or lasts for more than 3 days
- pain worsens or lasts for more than 10 days
These could be signs of a serious condition
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
OVERDOSAGE SECTION
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. In case of overdose, get medical help or contact Poison Control Center right away. 1-800-222-1222
DOSAGE & ADMINISTRATION SECTION
Directions: Do not take more than directed
Adults and children 12 year of age and over:
- take 2 tables every 4 to 6 hours while symptoms persist
- do not take more than 8 tablets in 24 hours unless directed by a doctor
Children under 12 years of age: do not use; this will provide more than the recommended dose (overdose) for children under 12 years of age and may cause liver damage
INACTIVE INGREDIENT SECTION
Inactive Ingredients: Microcrystalline Cellulose, Povidone, Sodium Starch Glycolate, Starch, Stearic Acid
HOW SUPPLIED
Product: 50090-3140
NDC: 50090-3140-0 2 TABLET in a PACKET / 500 in a BOX, UNIT-DOSE
ACETAMINOPHEN
Products#
Every source-derived product name is available through these pages.
- CETAFEN
- ACETAMINOPHEN
- MICROCRYSTALLINE CELLULOSE
- POVIDONE, UNSPECIFIED
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50090-3140 | 50090-3140-0 |
| 50332-0103 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
| STEARIC ACID | 4ELV7Z65AP | 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 |
|---|---|---|---|---|---|---|
| f4b4a6e4-b774-4740-9c66-5ac7b56051a3 | e012d671-4769-4164-930f-001422d02e22 | 2018-08-15 | Warnings | f4b4a6e4-b774-4740-9c66-5ac7b56051a3 e012d671-4769-4164-930f-001422d02e22 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.