CETAFEN EXTRA
- Manufacturer
- HART Health
- Effective date
- 2025-12-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 01:28:19
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient (in each caplet): Acetaminophen 500mg
OTC - PURPOSE SECTION
Purpose
Pain Reliever / Fever Reducer
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 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- rash
- blisters
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
- an allergic reaction occurs, seek medical help right away
- new symptms occur
- redness or swelling is present
- fever worsens or lasts more than 3 days
- pain worsens or lasts 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 a Poison Control Center right away. 1-800-222-1222.
DOSAGE & ADMINISTRATION SECTION
Directions:
Do not take more than directed
Adults and children 12 years of age and over:
- take 2 caplets every 4 to 6 hours while symptoms persist
- do not take more than 8 caplets in 24 hours unless directed by a doctor
Children under 12 years of age: ask a doctor
OTHER SAFETY INFORMATION
Other information:
- caplets enclosed in a sealed packet
- do not use if packet is torn, cut or open
- store at 59° to 86°F (15°-30°C)
- avoid excessive heat and humidity
INACTIVE INGREDIENT SECTION
Inactive Ingredients: corn starch, hypromellose, polyethylene glycol, povidone, pregelantized starch, sodium starch glycolate, stearic acid, titanium dioxide
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 198440 | acetaminophen 500 MG Oral Tablet | PSN | 3 |
| 1358835 | Cetafen Extra 500 MG Oral Tablet | PSN | 3 |
| 1358835 | acetaminophen 500 MG Oral Tablet [Cetafen] | SBD | 3 |
| 198440 | acetaminophen 500 MG Oral Tablet | SCD | 3 |
| 198440 | APAP 500 MG Oral Tablet | SY | 3 |
| 1358835 | APAP 500 MG Oral Tablet [Cetafen] | SY | 3 |
| 1358835 | Cetafen 500 MG Oral Tablet | SY | 3 |
DailyMed Product Concepts#
Products#
Every source-derived product name is available through these pages.
- CETAFEN EXTRA
- acetaminophen
- HYPROMELLOSES
- POLYETHYLENE GLYCOL, UNSPECIFIED
- STARCH, CORN
- STEARIC ACID
- TITANIUM DIOXIDE
- POVIDONE, UNSPECIFIED
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50332-0149 | 50332-0149-3, 50332-0149-4, 50332-0149-7, 50332-0149-8, 50332-0149-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| POVIDONE, UNSPECIFIED | FZ989GH94E | 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 |
|---|---|---|---|---|---|---|
| CETAFEN EXTRA | ACETAMINOPHEN | HART Health | 38db0b09-37f8-4fed-903e-81e89486b39b | 2025-12-24 | Warnings | 50332-0149-7 50332-0149-4 50332-0149-3 50332-0149-8 50332-0149-1 50332-0149 50332014907 50332014901 50332014904 50332014908 50332014903 0f2b113c-48f1-4a6f-8d6b-89c82a28e646 38db0b09-37f8-4fed-903e-81e89486b39b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
