697r timely 49483-697 extra strength acetaminophen 500 mg rapid release 400 count
c9f80d24-bd05-e1ce-e053-2995a90aa646
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active ingredient (in each caplet) Acetaminophen 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.
Active Ingredient
Active ingredient (in each caplet)
Acetaminophen 500 mg
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:
- 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
Description
Active ingredient (in each caplet) Acetaminophen 500 mg
Section 50565-1
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.
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 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
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 60561-8
Other information
• store between 20-25°C (68-77°F)
Structured Label Content
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.
Active Ingredient (55106-9)
Active ingredient (in each caplet)
Acetaminophen 500 mg
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:
- 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
Section 50565-1 (50565-1)
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.
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 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
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 60561-8 (60561-8)
Other information
• store between 20-25°C (68-77°F)
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:05:31.559239 · Updated: 2026-03-14T23:07:28.673990