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#

ProductACETAMINOPHEN
Active ingredientACETAMINOPHEN
Label structure14 sections

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

SPL UNCLASSIFIED SECTION

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

MM1MM1

MM2MM2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-1101-0EA - Each70518-1101e8c7a2b7-a06d-48dd-8afd-3c04972d6a3212023-01-09
70518-1101-1EA - Each70518-1101d95c317e-b01b-4cb0-a92a-47904174f8bf12023-01-09
49483-340-01EA - Each49483-34024193a13-9584-4d37-9512-ed41d3dd4b7c12016-12-07
49483-340-10EA - Each49483-340cd27a4fd-0234-4d68-9429-662a87a6322212021-05-05

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70518-110170518-1101-0, 70518-1101-1, 70518-1101-2
49483-340

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACETAMINOPHENACETAMINOPHENTIME CAP LABS INCc193dbc0-cc80-4a7c-aa29-457a20edf8352025-02-08WarningsExact identifier
ndc (product): 49483-340
02817ef4-f5f4-2c62-e063-6394a90a913b14f8f881-da8e-4c33-a1df-fd2c4d738aec2023-08-09WarningsExact identifier
spl set id: 14f8f881-da8e-4c33-a1df-fd2c4d738aec

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.