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
Acetaminophen
- Manufacturer
- Family Dollar (FAMILY WELLNESS)
- Effective date
- 2021-10-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:31:25
Label at a glance#
ProductAcetaminophen Extra Strength
Active ingredientACETAMINOPHEN
Label structure10 sections
Storage and handling
store between 15-30ºC (59-86ºF) avoid high humidity
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each gelcap)
Acetaminophen 500 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.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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.
Direction
- do not take more than directed (see Overdose warning)
- do not take more than 6 gelcaps in any 24-hour period
- adults and children 12 years and over
- take 2 gelcaps every 6 hours while symptoms last
- do not take more than 10 days unless directed by a doctor
- children under 12 years: do not use
other information
- store between 15-30ºC (59-86ºF)
- avoid high humidity
Inactive ingredients
ammonium hydroxide, croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, isopropyl alcohol, n-butyl alcohol, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, purified water, shellac, silicon dioxide, stearic acid, titanium dioxide
Questions or comments?
Call 1-877-753-3935 Monday-Friday 9 AM-5 PM EST
Principal Display Panel
COMPARE TO THE ACTIVE INGREDIENT OF TYLENOL® EXTRA STRENGTH RAPID RELEASE GELS†
EXTRA STRENGTH
Acetaminophen 500 mg
Pain Reliever/Fever Reducer
Adult
For Ages 12 Years and Over
RAPID RELEASE GELCAPS
†This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol® Extra Strength.Rapid Release Gels.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY: MIDWOOD BRANDS, LLC
10611 MONROE RD, MATTHEWS, NC 28105
Product Label
Products#
Every source-derived product name is available through these pages.
- Acetaminophen Extra Strength
- Acetaminophen
- CROSCARMELLOSE SODIUM
- D&C RED NO. 33
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- GELATIN
- HYDROXYPROPYL CELLULOSE (1600000 WAMW)
- HYPROMELLOSES
- FERROSOFERRIC OXIDE
- FERRIC OXIDE RED
- FERRIC OXIDE YELLOW
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE K30
- STARCH, CORN
- WATER
- SILICON DIOXIDE
- STEARIC ACID
- TITANIUM DIOXIDE
- ISOPROPYL ALCOHOL
- SHELLAC
- BUTYL ALCOHOL
- AMMONIA
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55319-541 | 55319-541-50 |
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 |
|---|---|---|---|---|---|---|
| 14494ec3-ed21-46c2-802a-e2124e370fdd | 9f4a5982-afa9-4ef7-a8cd-15d4590a1384 | 2021-10-20 | Warnings | 14494ec3-ed21-46c2-802a-e2124e370fdd 9f4a5982-afa9-4ef7-a8cd-15d4590a1384 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.