Naspen by Cho-A Pharm.Co., Ltd. Naspen

Naspen by

Drug Labeling and Warnings

Naspen by is a Otc medication manufactured, distributed, or labeled by Cho-A Pharm.Co., Ltd. . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NASPEN- acetaminophen capsule 
Cho-A Pharm.Co., Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Naspen

Active ingredients

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

Purpose

Pain reliever / fever reducer

Uses

temporarily relies minor aches and pains due to:

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

· toothache · arthalgia

temporarily reduces fever

Warnings

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

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

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

  • 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

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

Naspen

Naspen

NASPEN 
acetaminophen capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58354-123
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 1570 mg
Inactive Ingredients
Ingredient NameStrength
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
WATER (UNII: 059QF0KO0R)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
ANNATTO (UNII: 6PQP1V1B6O)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
Product Characteristics
ColororangeScoreno score
ShapeCAPSULESize22mm
FlavorImprint Code CA;NAS
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58354-123-021 in 1 BOX02/16/202205/18/2023
1NDC: 58354-123-0110 mg in 1 CAPSULE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/16/202205/18/2023
Labeler - Cho-A Pharm.Co., Ltd. (688056831)
Registrant - Cho-A Pharm.Co., Ltd. (688056831)
Establishment
NameAddressID/FEIBusiness Operations
Cho-A Pharm.Co., Ltd. 688056831manufacture(58354-123)

Revised: 6/2024
 

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