COPANTO- acetaminophen, pseudoephedrine hydrochloride, chlorpheniramine maleate tablet 
SAMSUNG PHARM. IND.CO.,LTD.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENT

Active ingredients: Acetaminophen 500mg Pseudoephedrine HCl 30mg Chlorpheniramine Maleate 3mg

INACTIVE INGREDIENT

Inactive ingredients: lactose, corn starch, microcrystalline cellulose, Hydroxypropylcellulose, magnesium stearate, hydroxypropyl methylcellulose, titanium oxide, propylene glycol

Uses

Uses: The relief of common cold symptoms(nasal mucus, nasal obstruction, sneeze, throat pain, chill, fever, headache, arthralgia, myalgia)

WARNINGS

Warnings: Ask a doctor or pharmacist before use if you are regularly drinking over three cups of alcohol per day or taking any other antipyretic and analgesics. Liver can be damaged if taken.

Caution if taken 1) Keep direction 2) Not taken with anti-tussive, expectorant, antipyretic, antihistamine, sedative 3) Let children take drug by protector 4) Not taken below 3 months. If not mandatory, do not let child take drug between 3 months and one year. 5) Stop taking medicine and ask a doctor or pharmacist before use even though adverse events are rarely reported below. (1) Rash, edema, breast burden, pale complexion, cold hand and foot, cold sweat, shortness of breath (2) High fever, rash, flare, bubble on whole skin, mouth, eye mucosa (3) Asthma 6) Barbital induced drug, tri-cyclic antidepressant and alcohol can reduce ability of acetaminophen metabolism and increase plasma half life. Alcohol could increase liver toxicity of acetaminophen overdose

Caution if taken 1) While taking a rash, redness, nausea, vomiting, constipation, anorexia, dysuria, dizziness and other symptoms when you stop asking your doctor or pharmacist 2) If you get drowsy, Be careful when driving a motor vehicle or operating machinery 3) Please don’t take drug and ask doctor or pharmacist if you can not feel better by several dose. 4) Don’t take for a long term

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Direction

Direction: Adults and children 12 years and over: take 2 tables every 6 hours, not to exceed 8 tables in 24 hours

Indication for usage

Indication for usage: Adults and children 12 years and over: take 2 tables every 6 hours, not to exceed 8 tables in 24 hours

Contraindication

Contraindication: 1) If you are anaphylactic to this drug (e.g., rash, flare, pruritis, edema) 2) Asthma patient after taking this drug or other anti-cold, antipyretic and analgesic.

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use 1) Family history to urticaria, contact dermatitis, bronchial asthma, allergic rhinitis, migrane, food allergy 2) Allergy experience to this drug (fever, rash, arthritis, asthma, pruritis) 3) Child below 14 years may be Infected by Chickenpox or influenza 4) Disease of Liver, kidney and thyroid disease, Diabetes, hypertension, weakling, high-fever 5) Glaucoma, dysuria 6) Pregnant or breast-feeding 7) People treated by MD or dentist

Caution of storage

Caution of storage: 1) Keep out of reach of children 2) Avoid sunlight and keep in cool and low humid place 3) Don’t abuse and replace with other container

Other information

Other information: Store in a hermetic container. Store between 1℃ to 30℃. 36 months from the manufacturing date

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of blister pack

COPANTO 
acetaminophen, pseudoephedrine hydrochloride, chlorpheniramine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49789-020
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg  in 670 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 670 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE3 mg  in 670 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE (UNII: J2B2A4N98G)  
STARCH, CORN (UNII: O8232NY3SJ)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
HYDROXYPROPYL CELLULOSE (1200000 MW) (UNII: RFW2ET671P)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize18mm
FlavorImprint Code SSCP
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49789-020-01670 mg in 1 BLISTER PACK; Type 0: Not a Combination Product03/01/201212/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/01/201212/01/2016
Labeler - SAMSUNG PHARM. IND.CO.,LTD. (687744425)
Registrant - SAMSUNG PHARM. IND.CO.,LTD. (687744425)
Establishment
NameAddressID/FEIBusiness Operations
SAMSUNG PHARM. IND.CO.,LTD.687744425manufacture(49789-020)

Revised: 3/2017
 
SAMSUNG PHARM. IND.CO.,LTD.