PANTO A- acetaminophen, chlorpheniramine maleate, guaifenesin liquid 
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.

----------

ACTIVE INGREDIENT

1 bottle contains: Acetaminophen 300mg, Chlorpheniramine Maleate 2.5mg, Guaifenesin 83.3mg

INACTIVE INGREDIENT

Inactive ingredients: Dl-methylephedrine HCl, Caffeine anhydrous, sugar, stevioside, citric acid, sodium citrate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, orange flavor, lemon flavor, peach flavor, drink flavor, glycerin, ethanol, purified water

PURPOSE

Uses: All symptoms of common cold

WARNINGS

Caution: 1. Warning 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

2. 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.

3. Ask a doctor or pharmacist before use 1) Anaphylactic history including family 2) Disease of Liver, kidney and thyroid disease, Diabetes, hypertension, weakling, high-fever 3) Heart failure, elderly 4) Pregnant or breast-feeding

4. Caution if taken 1) Anti-tussive, expectorant, other anti-cold, antipyretic, analgesic, antihistamine, sedative could not be taken simultaneously 2) Be careful when driving a motor vehicle or operating machinery. Successive application is prohibited for a long term 3) 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 4) Barbital induced drug, tri-cyclic antidepressant and alcohol can reduce ability of acetaminophen metabolism and increase plasma half life. Alcohol can increase liver toxicity of acetaminophen overdose

5. Adverse events : rash, flare, nausea, vomiting, loss of appetite, dizziness.

6. Et cetera Keep out of reach of children. Avoid sunlight and keep in cool and low humid place.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Indication and usage: Adults: take 30mL, 3 times a day

Direction

Adults: take 30mL, 3 times a day

STORAGE AND HANDLING

Storage and handling: Keep out of reach of children. Avoid sunlight and keep in cool and low humid place. Store in a hermetic container. 24 months from the manufacturing date.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of bottle

PANTO A 
acetaminophen, chlorpheniramine maleate, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49789-040
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN300 mg  in 30 mL
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2.5 mg  in 30 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN83.3 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
METHYLEPHEDRINE HYDROCHLORIDE, (+/-)- (UNII: 99214P83XM)  
SUCROSE (UNII: C151H8M554)  
STEVIOSIDE (UNII: 0YON5MXJ9P)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49789-040-0130 mL in 1 BOTTLE; 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(49789-040)

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