Indications and uses
temporarily relieves minor aches and pains due to: the common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever
Extra Strength Acetaminophen Tablets
- Manufacturer
- CVS PHARMACY, INC. | ELYSIUM PHARMACEUTICALS LIMITED
- Effective date
- 2017-11-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:52:56
Label at a glance#
ProductExtra Strength Acetaminophen
Active ingredientAcetaminophen
Label structure10 sections
Dosage and administration
do not take more than directed (see Overdose warning) adults and children 12 years and over take 2 caplets every 6 hours while symptoms last do not take more than 6 caplets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor
Storage and handling
Store the product at controlled room temperature 15°-30°C (59°-86°F). Protect from light, moisture and freezing.
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each caplet)
Acetaminophen 500 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- the common cold
- headache
- backache
- minor pain of arthritis
- toothache
- muscular aches
- premenstrual and menstrual cramps
- temporarily reduces fever
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
SPL UNCLASSIFIED SECTION
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
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have liver disease
OTC - ASK DOCTOR/PHARMACIST SECTION
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.
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.
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 and children 12 years and over |
|
| children under 12 years | ask a doctor |
Other information
- Store the product at controlled room temperature 15°-30°C (59°-86°F).
- Protect from light, moisture and freezing.
Inactive ingredients
hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, polyvinyl pyrrolidone, pregelatinized starch, stearic acid powder, talc, titanium dioxide
Questions or comments?
Call toll free: 1-855-215-8180
PRINCIPAL DISPLAY PANEL
CVS Extra Strength Acetaminophen Tablets, 500 mg
NDC 69842-390-54
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69842-390-54 | Extra Strength Acetaminophen | 15 in 1 CARTON | TABLET, FILM COATED | 15 | 1 | |
| 69842-390-54 | Extra Strength Acetaminophen | 2 in 1 POUCH | TABLET, FILM COATED | 2 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Extra Strength Acetaminophen
- Acetaminophen
- STARCH, PREGELATINIZED CORN
- POVIDONE
- hypromellose, unspecified
- magnesium stearate
- polyethylene glycol, unspecified
- CELLULOSE, MICROCRYSTALLINE
- STEARIC ACID
- TALC
- titanium dioxide
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69842-390 | 69842-390-54 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Acetaminophen | 362O9ITL9D | ACTIB |
| STARCH, PREGELATINIZED CORN | O8232NY3SJ | IACT |
| POVIDONE | FZ989GH94E | IACT |
| hypromellose, unspecified | 3NXW29V3WO | IACT |
| magnesium stearate | 70097M6I30 | IACT |
| polyethylene glycol, unspecified | 3WJQ0SDW1A | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TALC | 7SEV7J4R1U | IACT |
| titanium dioxide | 15FIX9V2JP | IACT |
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 |
|---|---|---|---|---|---|---|
| Extra Strength Acetaminophen | ACETAMINOPHEN | CVS PHARMACY, INC. | 3f9c230b-e6ea-4786-992b-9c7204425209 | 2017-11-09 | Warnings | 69842-390-54 69842-390 69842039054 8e71c727-66ab-497b-ad8e-0230b43f9a1d 3f9c230b-e6ea-4786-992b-9c7204425209 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.