673t Timely Extra Strength Acetaminophen Gelcaps
48912649-9fa1-a11f-e063-6294a90a8a72
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active ingredient (in each gelcap) Acetaminophen USP 500 mg
Medication Information
Warnings and Precautions
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.
Indications and Usage
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
Dosage and Administration
Directions
- do not take more than directed (see overdose warning)
| adults and children 12 years and over |
|
| children under 12 years | ask a doctor |
Description
Active ingredient (in each gelcap) Acetaminophen USP 500 mg
Section 34088-5
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.
Section 50565-1
Keep out of reach of children.
Section 50566-9
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.
Section 50568-5
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Section 50569-3
Ask a doctor before use if you have liver disease
Section 50570-1
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
Section 51727-6
Inactive ingredients colloidal anhydrous silica, croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, ferric oxide red, ferric oxide yellow, ferrosoferric oxide, gelatin, hypromellose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide
Section 51945-4
Section 53413-1
Questions or comments? Call 1-877-290-4008
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1
Purpose
Pain reliever/fever reducer
Section 55106-9
Active ingredient (in each gelcap)
Acetaminophen USP 500 mg
Section 60561-8
Other information
- each gelcap contains: sodium 1 mg
- store between 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F)
- avoid high humidity
Structured Label Content
Indications and Usage (34067-9)
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
Dosage and Administration (34068-7)
Directions
- do not take more than directed (see overdose warning)
| adults and children 12 years and over |
|
| children under 12 years | ask a doctor |
Warnings and Precautions (34071-1)
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.
Section 34088-5 (34088-5)
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.
Section 50565-1 (50565-1)
Keep out of reach of children.
Section 50566-9 (50566-9)
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.
Section 50568-5 (50568-5)
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Section 50569-3 (50569-3)
Ask a doctor before use if you have liver disease
Section 50570-1 (50570-1)
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
Section 51727-6 (51727-6)
Inactive ingredients colloidal anhydrous silica, croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, ferric oxide red, ferric oxide yellow, ferrosoferric oxide, gelatin, hypromellose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide
Section 51945-4 (51945-4)
Section 53413-1 (53413-1)
Questions or comments? Call 1-877-290-4008
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1 (55105-1)
Purpose
Pain reliever/fever reducer
Section 55106-9 (55106-9)
Active ingredient (in each gelcap)
Acetaminophen USP 500 mg
Section 60561-8 (60561-8)
Other information
- each gelcap contains: sodium 1 mg
- store between 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F)
- avoid high humidity
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:08:28.114493 · Updated: 2026-03-14T23:12:42.073607