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
Acetaminophen
- Manufacturer
- FREDS, INC
- Effective date
- 2017-07-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:52:13
Label at a glance#
ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure18 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
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient
(in each Caplet)
Acetaminophen, USP 500 mg
Purpose
Pain reliever/fever reducer
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
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 other 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.
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
■ 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
Other information
■ store between 20-25°C (68-77°F). See USP Controlled Room Temperature
■ See end panel for lot number and expiration date
Inactive ingredients
hydroxypropyl methyl cellulose, pregelatinized starch, povidone k-30, polyethylene glycol, stearic acid, sodium starch glycolate
Questions or comments?
call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST
EXTRA STRENGTH PAIN RELIEVER ACETAMINOPHEN, USP 500 mg Pain Reliever/Fever Reducer100 CAPLETS** ** Capsule-Shaped Tablets 500 mg each
EXTRA STRENGTH PAIN RELIEVER ACETAMINOPHEN, USP 500 mg Pain Reliever/Fever Reducer 500 CAPLETS 500 mg each
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55315-989-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-dc67-f424-e053-dadaa90a57ce | EXTRA STRENGTH PAIN RELIEVER ACETAMINOPHEN, USP 500 mg Pain Reliever/Fever Reducer |
| 55315-989-50 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-dc67-f424-e053-dadaa90a57ce | EXTRA STRENGTH PAIN RELIEVER ACETAMINOPHEN, USP 500 mg Pain Reliever/Fever Reducer |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55315-989-10 | Acetaminophen | 100 in 1 BOTTLE | CAPSULE | 100 | 1 | |
| 55315-989-50 | Acetaminophen | 500 in 1 BOTTLE | CAPSULE | 500 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Acetaminophen
- POLYETHYLENE GLYCOLS
- HYPROMELLOSES
- STARCH, PREGELATINIZED CORN
- POVIDONE K30
- STEARIC ACID
- SODIUM STARCH GLYCOLATE TYPE A POTATO
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55315-989 | 55315-989-10, 55315-989-50 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYETHYLENE GLYCOLS | 3WJQ0SDW1A | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| STARCH, PREGELATINIZED CORN | O8232NY3SJ | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | 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 |
|---|---|---|---|---|---|---|
| 54899dc4-b49b-2b10-e054-00144ff8d46c | 54899dc4-b49a-2b10-e054-00144ff8d46c | 2017-07-17 | Warnings | 54899dc4-b49b-2b10-e054-00144ff8d46c 54899dc4-b49a-2b10-e054-00144ff8d46c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.