ACETAMINOPHEN
- Manufacturer
- WAL-MART STORES INC | TIME CAP LABORATORIES, INC | TIME CAP LABORATORIES, INC.
- Effective date
- 2025-01-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 00:53:15
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient (in each caplet)
acetaminophen 500 mg
OTC - PURPOSE SECTION
Purpose
Pain reliever/ fever reducer
INDICATIONS & USAGE SECTION
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 SECTION
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 8 caplets in 24 hours,which is the maximum daily amount
- 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.
OTC - DO NOT USE SECTION
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
- for more than 10 days for pain unless directed by a doctor
- for more than 3 days for fever unless dierected by a doctor
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
OTC - STOP USE SECTION
Stop using and ask a doctor if
- symptoms do not improve
- new symptoms occur
- pain or fever persists or gets worse
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.
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.
DOSAGE & ADMINISTRATION SECTION
Directions
- do not take more than directed
adults and children 12 years and over
- take 2 caplets(1,000 mg) every 6 hours while symptoms last
- do not take more than 6 caplets(3,000 mg) 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 SAFETY INFORMATION
Other information
- SODIUM FREE
- store at 25 0C (77 0F) excursions permitted between 15 0-30 0C (59 0-86 0F)
- use by expiration date on package
INACTIVE INGREDIENT SECTION
Inactive ingredients: hypromellose, mineral oil, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid, titanium dioxide
*may contain this ingredient
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49035-755-50 | ACETAMINOPHEN | 500 in 1 BOTTLE | TABLET, COATED | 500 | 4 | |
| 49035-755-88 | ACETAMINOPHEN | 1000 in 1 PACKAGE | TABLET, COATED | 1000 | 4 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- ACETAMINOPHEN
- STEARIC ACID
- TITANIUM DIOXIDE
- STARCH, CORN
- SODIUM STARCH GLYCOLATE TYPE A CORN
- HYPROMELLOSES
- MINERAL OIL
- POVIDONE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 49035-755 | 49035-755-50, 49035-755-88 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| SODIUM STARCH GLYCOLATE TYPE A CORN | AG9B65PV6B | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| POVIDONE | FZ989GH94E | 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 |
|---|---|---|---|---|---|---|
| ACETAMINOPHEN | ACETAMINOPHEN | WAL-MART STORES INC | 8f221fdb-8138-c1a8-e053-2995a90a29c2 | 2025-01-11 | Warnings | 49035-755-50 49035-755-88 49035-755 49035075588 49035075550 2b6c0fa2-3f13-50df-e063-6294a90a044d 8f221fdb-8138-c1a8-e053-2995a90a29c2 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
