197 650mg Extended Release Acetaminophen Tablets
fc5fb080-bb9b-3283-e053-6394a90aabfb
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen USP, 650 mg
Purpose
Pain reliever/fever reducer
Medication Information
Purpose
Pain reliever/fever reducer
Description
Acetaminophen USP, 650 mg
Uses
temporarily relieves minor aches and pains due to:
■ minor pain of arthritis
■ muscular aches
■ backache
■ premenstrual and menstrual cramps
■ the common
cold
■ headache
■ toothache
■ temporarily reduces
fever
Label
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.
Directions
■ do not take more than directed (see overdose warning)
| adults |
■ 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 |
| under 18 years of age | ■ ask a doctor |
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
Other Information
■ store between 20–25°C (68–77°F)
■ not made with Natural Rubber Latex
■ do not use if inner seal is broken or missing
Inactive Ingredients
hydroxy ethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid
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.
If Pregnant Or Breast Feeding,
ask a professional before use.
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.
Active Ingredient (in Each Caplet)
Acetaminophen USP, 650 mg
Ask A Doctor Before Use If You Have
liver disease
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin
Structured Label Content
Uses
temporarily relieves minor aches and pains due to:
■ minor pain of arthritis
■ muscular aches
■ backache
■ premenstrual and menstrual cramps
■ the common
cold
■ headache
■ toothache
■ temporarily reduces
fever
Label
Purpose
Pain reliever/fever reducer
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.
Directions
■ do not take more than directed (see overdose warning)
| adults |
■ 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 |
| under 18 years of age | ■ ask a doctor |
Do Not Use (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
Other Information (Other information)
■ store between 20–25°C (68–77°F)
■ not made with Natural Rubber Latex
■ do not use if inner seal is broken or missing
Inactive Ingredients (Inactive ingredients)
hydroxy ethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid
Stop Use and Ask A Doctor If (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.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)
ask a professional before use.
Keep Out of Reach of Children. (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.
Active Ingredient (in Each Caplet) (Active Ingredient (in each caplet))
Acetaminophen USP, 650 mg
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
liver disease
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
taking the blood thinning drug warfarin
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:03:16.216836 · Updated: 2026-03-14T23:03:15.788850