Naspen

Manufacturer
Cho-A Pharm.Co., Ltd.
Effective date
2022-02-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:08:35

Label at a glance#

ProductNaspen
Active ingredientACETAMINOPHEN
Label structure9 sections

Indications and uses

temporarily relies minor aches and pains due to: · cold · headache · neuralgia · muscle ache · period pain · sprain · toothache · arthalgia temporarily reduces fever

Dosage and administration

Directions Adults and children 12 years and over · take 2 caps once (4-6 hours 3 times) · do not take more than 12 capsules a day. · take minimum effective dose for shortest possible period. Children under 12 years · ask a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg ------------------------------------------ Pain reliver / fever reducer

Purpose

OTC - PURPOSE SECTION

Pain reliever / fever reducer

Uses

INDICATIONS & USAGE SECTION

temporarily relies minor aches and pains due to:

· cold · headache · neuralgia · muscle ache · period pain · sprain

· toothache · arthalgia

temporarily reduces fever

Warnings

WARNINGS SECTION

Warnings

Liver Warning: This product contains acetaminophen.

Severe lover 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 tight 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: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children 12 years and over

· take 2 caps once (4-6 hours 3 times)

· do not take more than 12 capsules a day.

· take minimum effective dose for shortest possible period.

Children under 12 years

· ask a doctor

Other Information

OTHER SAFETY INFORMATION

  • store in a dry and cool place, away from the direct sunlight.
  • to avoid misuse, do not change container.
  • do not use if carton is opened.

Inactive ingredients

INACTIVE INGREDIENT SECTION

annatto extract, gelatin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan solution,

Naspen

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NaspenNaspen

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58354-12358354-123-01, 58354-123-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1b8cbbb6-2faa-cfdb-e063-6294a90ae496d82b13c3-7fda-4aee-e053-2995a90aabac2024-06-23WarningsExact identifier
spl set id: d82b13c3-7fda-4aee-e053-2995a90aabac

Reported adverse events (FAERS/openFDA)#

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