Indications and uses
temporarily relieves minor aches and pains due to: headache the common cold backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever
Pain Reliever
- Manufacturer
- Walgreen Company | LNK International, Inc.
- Effective date
- 2020-02-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:41:12
Label at a glance#
ProductPain Reliever 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 gelcaps every 4 to 6 hours while symptoms last do not take more than 10 gelcaps in 24 hours, unless directed by a doctor do not take for more than 10 days unless directed by a doctor children under 12 years: ask a doctor
Storage and handling
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) avoid high humidity use by expiration date on package
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each gelcap)
Acetaminophen 325 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- headache
- the common cold
- 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
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 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 12 years and over
- take 2 gelcaps every 4 to 6 hours while symptoms last
- do not take more than 10 gelcaps in 24 hours, unless directed by a doctor
- do not take for more than 10 days unless directed by a doctor
- children under 12 years: ask a doctor
Other information
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- avoid high humidity
- use by expiration date on package
Inactive ingredients
corn starch, croscarmellose sodium, FD&C red # 40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, propylene glycol, shellac glaze, stearic acid, titanium dioxide
Questions or comments?
1-800-426-9391
Principal display panel
Well at
Walgreens
NDC 0363-6780-20
REGULAR STRENGTH
Pain Reliever
Acetaminophen 325 mg /
Pain Reliever / Fever Reducer
225 GELCAPS
Fast-Release
Quick Gels™
Actual Size
Compare to Regular Strength Tylenol® active ingredient‡‡
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®.
Walgreens Pharmacist Recommended.
Walgreens Pharmacist Survey Study,
November 2014.
50844 REV0417A67820 ORG0515-F_R02
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD, DEERFIELD, IL 60015
100%SATISFACTION GUARANTEED
walgreens.com ©2016 Walgreen Co.
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 |
Products#
Every source-derived product name is available through these pages.
- Pain Reliever Regular Strength
- Acetaminophen
- STARCH, CORN
- CROSCARMELLOSE SODIUM
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- GELATIN, UNSPECIFIED
- HYPROMELLOSE, UNSPECIFIED
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE, UNSPECIFIED
- PROPYLENE GLYCOL
- STEARIC ACID
- TITANIUM DIOXIDE
- HYDROXYPROPYL CELLULOSE, UNSPECIFIED
- FERROSOFERRIC OXIDE
- FERRIC OXIDE RED
- FERRIC OXIDE YELLOW
- SHELLAC
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0363-6780 | 0363-6780-20 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / ORAL | 736 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, DELAYED RELEASE / ORAL | 105 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, EXTENDED RELEASE / ORAL | 90 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, EXTENDED RELEASE / ORAL | 1229 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | IMPLANT / SUBCUTANEOUS | 6 mg | ||
| GELATIN | GELATIN | 2G86QN327L | POWDER, FOR SUSPENSION / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, LIQUID FILLED / ORAL | 12 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SPONGE / TOPICAL | 0.01 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, CHEWABLE / ORAL | 180 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | DROPS / ORAL | NA | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | MOUTHWASH / BUCCAL | 0.01 mg/1ml | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, COATED PELLETS / ORAL | 3.32 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | SYSTEM / TOPICAL | 41 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TROCHE / ORAL | 50 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / OPHTHALMIC | 1 %w/v | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION, EXTENDED RELEASE / ORAL | 113 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, DELAYED RELEASE / ORAL | 36 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, COATED / ORAL | 42.4 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / TOPICAL | 8 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE, DENTIFRICE / DENTAL | 0.4 %w/w | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, COATED / ORAL | 288 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | INJECTION / INTRAMUSCULAR | 1 %w/v | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, EXTENDED RELEASE / ORAL | 101 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, EXTENDED RELEASE / ORAL | 67 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CREAM / TOPICAL | 80 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, CHEWABLE / ORAL | 48 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | DROPS / ORAL | 0.2 mg/1ml | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / SUBCUTANEOUS | 1.4 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / INTRAVENOUS | 5 %w/v | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 14 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / SUBLINGUAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SOAP / TOPICAL | 1 %w/w | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, CHEWABLE / ORAL | 216 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | EMULSION / TOPICAL | NA | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | PASTILLE / ORAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | PASTE / DENTAL | 0.5 %w/w | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, ORALLY DISINTEGRATING / ORAL | 184 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FILM COATED / ORAL | 330 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CLOTH / TOPICAL | 0.03 mg/mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / SUBLINGUAL | 10 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, DELAYED RELEASE / ORAL | 0.02 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET / ORAL | 216 mg | ||
| GELATIN | GELATIN | 2G86QN327L | PASTE / DENTAL | 252 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE / ORAL | 1072 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CONCENTRATE / ORAL | 7000 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 24 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, EXTENDED RELEASE / ORAL | 8 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 19 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET / ORAL | 1127 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | INSERT, EXTENDED RELEASE / OPHTHALMIC | 0.4 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET / PERIODONTAL | 3.44 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, COATED / ORAL | 3.17 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION/ DROPS / TOPICAL | 0.75 %w/v | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | PELLET / ORAL | 162 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / VAGINAL | 4 %w/w | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, DELAYED RELEASE / ORAL | 79 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, CHEWABLE / ORAL | 0.41 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / DENTAL | NA |
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 |
|---|---|---|---|---|---|---|
| a417f889-2437-4c8a-8944-c47f225f0900 | 36bfcf25-4e62-425c-94f5-1fe035ac88a3 | 2020-02-11 | Warnings | a417f889-2437-4c8a-8944-c47f225f0900 36bfcf25-4e62-425c-94f5-1fe035ac88a3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.