PANTO A

Dosage form: liquid
Ingredients: ACETAMINOPHEN 300mg in 30mL, CHLORPHENIRAMINE MALEATE 2.5mg in 30mL, GUAIFENESIN 83.3mg in 30mL
Labeler: SAMSUNG PHARM IND. CO., LTD.
NDC Code: 49789-040

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.

Drug Facts

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

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

Uses:
All symptoms of common cold

Direction
Adults: take 30mL, 3 times a day

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

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

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.

PANTO A 
acetaminophen, chlorpheniramine maleate, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49789-040
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN300 mg  in 30 mL
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE2.5 mg  in 30 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN83.3 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
METHYLEPHEDRINE HYDROCHLORIDE, DL- 
SUCROSE 
STEVIOSIDE 
CITRIC ACID MONOHYDRATE 
SODIUM CITRATE 
METHYLPARABEN 
PROPYLPARABEN 
GLYCERIN 
Packaging
#Item CodePackage Description
1NDC:49789-040-0130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/01/2012
Labeler - SAMSUNG PHARM IND. CO., LTD. (687744425)
Registrant - SAMSUNG PHARM IND. CO., LTD. (687744425)
Establishment
NameAddressID/FEIOperations
SAMSUNG PHARM IND. CO., LTD.687744425manufacture

Revised: 07/2012
 
SAMSUNG PHARM IND. CO., LTD.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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