Indications and uses
temporarily relieves minor aches and pains due to : headache the common cold toothache backache muscular aches minor pain of arthritis premenstrual and menstrual cramps temporarily reduces fever
Pain Relief
- Manufacturer
- CVS Pharmacy | LNK International, Inc.
- Effective date
- 2021-10-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 11
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:34:13
Label at a glance#
ProductPain Relief Regular Strength
Active ingredientACETAMINOPHEN
Label structure9 sections
Dosage and administration
do not take more than directed adults and children 12 years and over take 2 tablets every 4 to 6 hours while symptoms last do not take more than 10 tablets in 24 hours do not take for more than 10 days unless directed by a doctor children 6-11 years take 1 tablet every 4 to 6 hours while symptoms last do not take more than 5 tablets in 24 hours do not take for more than 5 days unless directed by a doctor childre...
Storage and handling
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each tablet)
Acetaminophen 325 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to :
- headache
- the common cold
- toothache
- backache
- muscular aches
- minor pain of arthritis
- premenstrual and menstrual cramps
- temporarily reduces fever
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.
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 the user has
liver disease.
Ask a doctor or pharmacist before use if the user is
taking the blood thinning drug warfarin.
Stop use and ask a doctor if
- new symptoms occur
- 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
- redness or swelling is present
- fever gets worse or lasts more than 3 days
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.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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
adults and |
|
children |
|
| children under 6 years | ask a doctor |
Other information
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- see end flap for expiration date and lot number
Inactive ingredients
corn starch, povidone, sodium starch glycolate, stearic acid
Questions or comments?
1-800-426-9391
Principal display panel
CVS Health™
Compare to the active ingredient in Regular Strength Tylenol®*
Tablets
NDC 59779-104-13
Regular Strength
Pain Relief
ACETAMINOPHEN, 325 mg
Pain reliever/Fever reducer
Aspirin free
250 TABLETS Actual Size
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Regular Strength Tylenol®.
50844 ORG061510413
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2015 CVS/pharmacy
CVS.com 1-800-SHOP CVS
Made in the U.S.A with domestic
and imported ingredients.
V-11112
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 5 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 5 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | 5 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | 5 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 5 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 5 |
Products#
Every source-derived product name is available through these pages.
- Pain Relief Regular Strength
- Acetaminophen
- STARCH, CORN
- POVIDONE
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 59779-104 | 59779-104-12, 59779-104-13 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| STARCH, CORN | O8232NY3SJ | IACT |
| POVIDONE | FZ989GH94E | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, COATED / ORAL | 256 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION, EXTENDED RELEASE / ORAL | 113 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | POWDER, FOR SUSPENSION / ORAL | 35 mg/5ml | ||
| POVIDONES | POVIDONE | FZ989GH94E | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SOAP / TOPICAL | 6 %w/w | ||
| POVIDONES | POVIDONE | FZ989GH94E | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 32 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SHAMPOO / TOPICAL | 9.7 %w/w | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | PASTILLE / ORAL | NA | ||
| POVIDONES | POVIDONE | FZ989GH94E | SUSPENSION/ DROPS / OPHTHALMIC | 0.6 %w/v | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET / SUBLINGUAL | 6 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION / ORAL | 900 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, EXTENDED RELEASE / ORAL | 194 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / BUCCAL | 16.6 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CONCENTRATE / ORAL | NA | ||
| POVIDONES | POVIDONE | FZ989GH94E | CAPSULE, COATED PELLETS / ORAL | 10.03 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 19 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / BUCCAL | 6 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | SUSPENSION / ORAL | 20 mg/5ml | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | POWDER, FOR SUSPENSION / ORAL | 1203 mg/5ml | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE, EXTENDED RELEASE / ORAL | 64 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, CHEWABLE / ORAL | 180 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CREAM / VAGINAL | 1088 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | INSERT / VAGINAL | 147 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | EMULSION / TOPICAL | NA | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, FILM COATED / ORAL | 240 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, COATED / ORAL | 42.4 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, ORALLY DISINTEGRATING / ORAL | 15.03 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | EMULSION / ORAL | NA | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / SUBLINGUAL | 409 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE / ORAL | 5785 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET / ORAL | 216 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | CAPSULE, DELAYED RELEASE / ORAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | OINTMENT / TOPICAL | 15 %w/w | ||
| POVIDONES | POVIDONE | FZ989GH94E | INJECTION / INTRAMUSCULAR | 0.2 %w/v | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, EXTENDED RELEASE / ORAL | 200 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TROCHE / ORAL | 30 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | POWDER, FOR SUSPENSION / ORAL | 34 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / SUBLINGUAL | 9 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, EXTENDED RELEASE / ORAL | 101 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CREAM / TOPICAL | 190 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | LOTION / TOPICAL | 80 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / VAGINAL | 4 %w/w | ||
| POVIDONES | POVIDONE | FZ989GH94E | IMPLANT / SUBCUTANEOUS | 6 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, DELAYED RELEASE / ORAL | 713 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | CAPSULE / ORAL | 300 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / TOPICAL | 8 %w/w | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 21 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | SUSPENSION / OPHTHALMIC | 1.8 %w/v | ||
| POVIDONES | POVIDONE | FZ989GH94E | CAPSULE, EXTENDED RELEASE / ORAL | 56 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 120 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, EXTENDED RELEASE / ORAL | 184 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, CHEWABLE / ORAL | 180 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | SOLUTION / OPHTHALMIC | 1.8 %w/v | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, ORALLY DISINTEGRATING / ORAL | 10 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | SYSTEM / TOPICAL | 41 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, COATED / ORAL | 49.2 mg |
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 |
|---|---|---|---|---|---|---|
| b3113d28-7bd0-459a-b9b0-c40792ef912b | d4e5d776-7deb-4f4f-b6e6-99dee0739323 | 2022-11-09 | Warnings | d4e5d776-7deb-4f4f-b6e6-99dee0739323 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.