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
Acetaminophen Extended Release Tablets 650 mg
- Manufacturer
- Bi-Mart | Granules India Limited
- Effective date
- 2025-03-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 00:57:38
Label at a glance#
ProductACETAMINOPHEN
Active ingredientACETAMINOPHEN
Label structure15 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 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 everyday 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 drugs 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 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 health professional before use.
Keep out of reach of children
Overdose warning:In case of overdose, get medical help or contact a Poison Control Center (1-800 222-1222) right away. 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)
• DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.
INACTIVE INGREDIENTS
hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid
QUESTIONS ?
call toll free 1-844-912-4012
PRINCIPAL DISPLAY PANEL
NDC 37835-512-01
Compare to the active ingredients in Tylenol ® 8 HR Arthritis Pain*
Acetaminophen Extended-release Tablets
650 mg
Pain reliever/fever reducer
For the Temporary Relief of Minor Arthritis Pain
100 Caplets
*This product is not manufactured or distributed by the owner of the registered trademark Tylenol ® 8 HR Arthritis Pain.
Distributed by:
BI-MART
Eugene, OR 97402
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1148399 | acetaminophen 650 MG 8HR Extended Release Oral Tablet | PSN | 1 |
| 1148399 | 8 HR acetaminophen 650 MG Extended Release Oral Tablet | SCD | 1 |
| 1148399 | 8 HR APAP 650 MG Extended Release Oral Tablet | SY | 1 |
| 1148399 | acetaminophen 650 MG 8 HR Extended Release Oral Tablet | SY | 1 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 37835-512-01 | ACETAMINOPHEN | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- ACETAMINOPHEN
- HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)
- HYPROMELLOSE 2910 (6 MPA.S)
- MAGNESIUM STEARATE
- CELLULOSE, MICROCRYSTALLINE
- POLYETHYLENE GLYCOL 400
- POVIDONE K30
- STARCH, CORN
- SODIUM STARCH GLYCOLATE TYPE A CORN
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 37835-512 | 37835-512-01 |
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 |
|---|---|---|---|---|---|---|
| 30d44923-02f8-c4ea-e063-6294a90a935a | ab2f0834-bdef-4862-b549-5a8161f8420b | 2025-03-01 | Warnings | 30d44923-02f8-c4ea-e063-6294a90a935a ab2f0834-bdef-4862-b549-5a8161f8420b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.