704r target acetaminophen extended-release tablets usp, 650 mg
e8b48f37-6023-ba04-e053-2a95a90a0e6c
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active ingredient (in each caplet) Acetaminophen 650 mg
Medication Information
Warnings and Precautions
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 6 caplets 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.
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 650 mg
Indications and Usage
Uses
temporarily relieves minor aches and pains due to:
- muscular aches
- backache
- minor pain of arthritis
- toothache
- premenstrual and menstrual cramps
- headache
- the common cold
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 8 hours with water
- swallow whole; do not crush, chew, split or dissolve
- do not take more than 6 caplets in 24 hours
- do not use for more than 10 days unless directed by a doctor
children under 12 years: do not use
Description
Active ingredient (in each caplet) Acetaminophen 650 mg
Section 44425-7
Other information
- store between 20-25°C (68-77°F)
- The FDA approved Dissolution methods differ from USP
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 using 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
carnauba wax, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin
Section 51945-4
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
Questions or comments?
Call 1-800-910-6874
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 6 caplets 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.
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 650 mg
Indications and Usage (34067-9)
Uses
temporarily relieves minor aches and pains due to:
- muscular aches
- backache
- minor pain of arthritis
- toothache
- premenstrual and menstrual cramps
- headache
- the common cold
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 8 hours with water
- swallow whole; do not crush, chew, split or dissolve
- do not take more than 6 caplets in 24 hours
- do not use for more than 10 days unless directed by a doctor
children under 12 years: do not use
Section 44425-7 (44425-7)
Other information
- store between 20-25°C (68-77°F)
- The FDA approved Dissolution methods differ from USP
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 using 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
carnauba wax, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin
Section 51945-4 (51945-4)
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)
Questions or comments?
Call 1-800-910-6874
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:02:52.760007 · Updated: 2026-03-14T23:02:39.250584