Indications and 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
197 650mg Extended Release Acetaminophen Tablets
- Manufacturer
- Medline Industries, LP
- Effective date
- 2024-07-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 00:15:05
Label at a glance#
ProductMedline
Active ingredientACETAMINOPHEN
Label structure8 sections
Dosage and administration
■ 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
Contacts and useful links#
Label contents#
Full prescribing information#
Active Ingredient (in each caplet)
Acetaminophen USP, 650 mg
Purpose
Pain reliever/fever reducer
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
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.
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
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
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.
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 |
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
Label
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1148399 | acetaminophen 650 MG 8HR Extended Release Oral Tablet | PSN | 3 |
| 1148399 | 8 HR acetaminophen 650 MG Extended Release Oral Tablet | SCD | 3 |
| 1148399 | 8 HR APAP 650 MG Extended Release Oral Tablet | SY | 3 |
| 1148399 | acetaminophen 650 MG 8 HR Extended Release Oral Tablet | SY | 3 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53329-197-29 | Medline | 50 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 50 | 3 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Medline
- acetaminophen
- POLYETHYLENE GLYCOL, UNSPECIFIED
- HYPROMELLOSE, UNSPECIFIED
- SODIUM STARCH GLYCOLATE TYPE A
- POVIDONE
- MAGNESIUM STEARATE
- HYDROXYETHYL CELLULOSE, UNSPECIFIED
- MICROCRYSTALLINE CELLULOSE
- STARCH, CORN
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 53329-197 | 53329-197-29 |
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 |
|---|---|---|---|---|---|---|
| 53702072-01e0-b193-e063-6294a90ab7d2 | fc5fb080-bb9b-3283-e053-6394a90aabfb | 2026-06-04 | Warnings | fc5fb080-bb9b-3283-e053-6394a90aabfb |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.