ACETAMINOPHEN
- Manufacturer
- REMEDYREPACK INC.
- Effective date
- 2022-09-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 9
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:53:47
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet)
Acetaminophen 325 mg
OTC - PURPOSE SECTION
Purpose
Pain reliever/fever reducer
INDICATIONS & USAGE SECTION
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
WARNINGS SECTION
Warnings
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 12 tablets 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 directed 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 persist or get 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 tablets (650 mg) every 4 to 6 hours while symptoms last
- do not take more than 10 tablets (3,250 mg) in 24 hours, unless directed by a doctor
- do not use for more than 10 days unless directed by a doctor
children 6 years to under 12 years
- take 1 tablet (325 mg) every 4 to 6 hours while symptoms last
- do not take more than 5 tablets (1,625 mg) in 24 hours
- do not use for more than 5 days unless directed by a doctor
children under 6 years
ask a doctor
OTHER INFORMATION
Other information
- SODIUM FREE
- store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
- use by expiration date on package
INACTIVE INGREDIENT SECTION
Inactive ingredients
povidone, pregelatinized starch, sodium starch glycolate*, stearic acid
*may contain this ingredient
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DRUG: ACETAMINOPHEN
GENERIC: ACETAMINOPHEN
DOSAGE: TABLET
ADMINSTRATION: ORAL
NDC: 70518-1101-0
NDC: 70518-1101-1
NDC: 70518-1101-2
COLOR: white
SHAPE: ROUND
SCORE: No score
SIZE: 10 mm
IMPRINT: TCL340
PACKAGING: .30 in 1 BLISTER PACK
PACKAGING: 30 in 1 BLISTER PACK
PACKAGING: 20 in 1 BLISTER PACK
ACTIVE INGREDIENT(S):
- ACETAMINOPHEN 325mg in 1
INACTIVE INGREDIENT(S):
- POVIDONE
- STARCH, CORN
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- STEARIC ACID
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70518-1101-0 | EA - Each | 70518-1101 | e8c7a2b7-a06d-48dd-8afd-3c04972d6a32 | 1 | 2023-01-09 |
| 70518-1101-1 | EA - Each | 70518-1101 | d95c317e-b01b-4cb0-a92a-47904174f8bf | 1 | 2023-01-09 |
| 49483-340-01 | EA - Each | 49483-340 | 24193a13-9584-4d37-9512-ed41d3dd4b7c | 1 | 2016-12-07 |
| 49483-340-10 | EA - Each | 49483-340 | cd27a4fd-0234-4d68-9429-662a87a63222 | 1 | 2021-05-05 |
Products#
Every source-derived product name is available through these pages.
- ACETAMINOPHEN
- POVIDONE
- STARCH, CORN
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70518-1101 | 70518-1101-0, 70518-1101-1, 70518-1101-2 |
| 49483-340 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POVIDONE | FZ989GH94E | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
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 | TIME CAP LABS INC | c193dbc0-cc80-4a7c-aa29-457a20edf835 | 2025-02-08 | Warnings | 49483-340 |
| 02817ef4-f5f4-2c62-e063-6394a90a913b | 14f8f881-da8e-4c33-a1df-fd2c4d738aec | 2023-08-09 | Warnings | 14f8f881-da8e-4c33-a1df-fd2c4d738aec |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

