340R CVS 69842-968 Acetaminophen 325mg Tablets
- Manufacturer
- CVS HEALTH CORP | TIME CAP LABORATORIES, INC.
- Effective date
- 2025-02-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 00:55:18
Label at a glance#
ProductACETAMINOPHEN
Active ingredientACETAMINOPHEN
Label structure9 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet)
Acetaminophen 325 mg
OTC - PURPOSE SECTION
Purpose
Pain reliever/fever reducer
INDICATIONS & USAGE SECTION
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
WARNINGS SECTION
Warnings
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if
• adult takes more than 4,000 mg of acetaminophen in 24 hours
• child takes more than 5 doses in 24 hours, which is the maximum daily amount
• taken with other drugs containing acetaminophen
• adult has 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.
OTC - DO NOT USE SECTION
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
OTC - ASK DOCTOR SECTION
Ask a doctor before use if the user has liver disease
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin
OTC - STOP USE SECTION
Stop use and ask a doctor if
• pain gets worse or lasts more than 10 days in adults
• pain gets worse or lasts more than 5 days in children under 12 years
• 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.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
OVERDOSAGE SECTION
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.
DOSAGE & ADMINISTRATION SECTION
Directions
Do not take more than directed.
See overdose warning
| adults and children 12 years and over |
|
| children 6 years to under 12 years | • take 1 tablet every 4 to 6 hours while symptoms last • do not take more than 5 tablets in 24 hours • do not use for more than 5 days unless directed by a doctor |
| children under 6 years | ask a doctor |
OTHER SAFETY INFORMATION
Other information
• SODIUM FREE
• store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
• use by expiration date on package
INACTIVE INGREDIENT SECTION
Inactive ingredients
povidone, pregelatinized starch, sodium starch glycolate*, stearic acid
*may contain this ingredient
OTC - QUESTIONS SECTION
Questions or comments? Call 1-877-290-4008
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69842-968-01 | 2025-02-13 | C162847 | 48780-1 | 2cef2736-775a-d83d-e063-dadaa90ab31f | 340R CVS 69842-968 Acetaminophen 325mg Tablets |
| 69842-968-01 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-775a-d83d-e063-dadaa90ab31f | 340R CVS 69842-968 Acetaminophen 325mg Tablets |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69842-968-01 | ACETAMINOPHEN | 1 in 1 CARTON | TABLET | 1 | 4 | |
| 69842-968-01 | ACETAMINOPHEN | 100 in 1 BOTTLE | TABLET | 100 | 4 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69842-968-01 | EA - Each | 69842-968 | 213741e0-e10f-47b2-a5d8-9cf332f8c3c5 | 1 | 2023-12-05 |
Products#
Every source-derived product name is available through these pages.
- ACETAMINOPHEN
- POVIDONE
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- STEARIC ACID
- STARCH, CORN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69842-968 | 69842-968-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POVIDONE | FZ989GH94E | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
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 |
|---|---|---|---|---|---|---|
| ACETAMINOPHEN | ACETAMINOPHEN | CVS HEALTH CORP | bbc48c9e-7eb8-2c67-e053-2a95a90a8552 | 2025-02-13 | Warnings | 69842-968-01 69842-968 69842096801 2e010044-3dee-3a65-e063-6294a90a65a9 bbc48c9e-7eb8-2c67-e053-2a95a90a8552 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.