EXTRA STRENGTH ACETAMINOPHEN
- Manufacturer
- TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
- Effective date
- 2025-02-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 00:54:51
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each caplet)
Acetaminophen 500 mg
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 pain of arthritis
• the common cold
• toothache
• premenstrual and 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
• blisters
• rash
If a skin reaction occurs, stop use and seek medical help right away.
OTC - DO NOT USE SECTION
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
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have liver disease
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
OTC - STOP USE SECTION
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.
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.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
DOSAGE & ADMINISTRATION SECTION
Directions
- do not take more than directed (see overdose warning)
adults and children 12 years and over:
- take 2 caplets every 6 hours while symptoms last
- do not take more than 6 caplets in 24 hours, unless directed by a doctor
- do not use for more than 10 days unless directed by a doctor
children under 12 years:
- ask a doctor
OTHER SAFETY INFORMATION
Other information
• store between 20-25°C (68-77°F)
INACTIVE INGREDIENT SECTION
Inactive ingredients croscarmellose sodium, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, mica based pearlescent pigment, polyethylene glycol 400, polyethylene glycol 6000, polysorbate 80, povidone, pregelatinized starch
OTC - QUESTIONS SECTION
Questions or comments? Call 1-877-290-4008
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 49483-697-43 | 2025-02-10 | C162847 | 48780-1 | 2cef2736-7a6f-d83d-e063-dadaa90ab31f | 697R Timely 49483-697 Extra Strength Acetaminophen 500 mg Rapid Release 400 count |
| 49483-697-43 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-7a6f-d83d-e063-dadaa90ab31f | 697R Timely 49483-697 Extra Strength Acetaminophen 500 mg Rapid Release 400 count |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49483-697-43 | EXTRA STRENGTH ACETAMINOPHEN | 400 in 1 BOTTLE | TABLET | 400 | 3 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- EXTRA STRENGTH ACETAMINOPHEN
- Acetaminophen
- FD&C YELLOW NO. 6 ALUMINUM LAKE
- HYPROMELLOSE 2910 (6 MPA.S)
- POLYETHYLENE GLYCOL 400
- CROSCARMELLOSE SODIUM
- CROSPOVIDONE
- FD&C RED NO. 40 ALUMINUM LAKE
- POLYSORBATE 80
- POLYETHYLENE GLYCOL 6000
- MICA
- POVIDONE K30
- MAGNESIUM STEARATE
- STARCH, CORN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 49483-697 | 49483-697-43 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| EXTRA STRENGTH ACETAMINOPHEN | ACETAMINOPHEN | TIME CAP LABORATORIES, INC. | c9f80d24-bd05-e1ce-e053-2995a90aa646 | 2025-02-10 | Warnings | 49483-697-43 49483-697 49483069743 2dc52443-77b2-5143-e063-6394a90a4958 c9f80d24-bd05-e1ce-e053-2995a90aa646 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
