Label: PANCOLD A- acetaminophen, guaifenesin, pentoxyverine citrate, phenylpehrine hydcrochloride, chlorpheniramine maleate, caffeine anhydrous liquid

  • NDC Code(s): 51352-189-73, 51352-189-75
  • Packager: DONGWHA PHARM. CO. LTD.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 7, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS

    Active ingredients (in each 30 mL bottle)

    • Acetaminophen 300 mg
    • Guaifenesin 80 mg
    • Pentoxyverine citrate 15 mg
    • Phenylephrine Hydrochloride 10 mg
    • Chlorpheniramine maleate 2.5 mg
    • Caffeine 30 mg
  • PURPOSE

    Pain Reliever-Fever Reducer, Expectorant, Antitussive, Nasal Decongestant, Antihistamine, Pain reliever aid

  • INDICATIONS & USAGE

    Uses temporarily relieves these common cold symptoms:

    • runny nose & sneezing
    • nasal congestion
    • sore throat
    • cough
    • phlegm
    • chills
    • fever
    • headache
    • joint pain
    • muscle pain
  • WARNINGS SECTION

    Warnings

    Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 4,000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more glasses of alcohol everyday while using this product

    Allergy alert: acetaminophen mat cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    • Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
  • DO NOT USE

    Do not use

    • if you ever had an allergic reaction to this product or any of its ingredients
    • with any other drug containing acetaminophen. If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • If you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains MAOI, ask a doctor or pharmacist before taking this product.
    • If you are taking expectorants, other cold drugs, antipyretic-analgesics, sedatives, oral drugs containing antihistamines (oral drugs for rhinitis, motion sickness drugs, and allergy drugs)
  • ASK A DOCTOR

    Ask a doctor before use if you have

    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to enlarge prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma or emphysema
    • cough that occurs with too much phlegm (mucus)
    • glaucoma (eye pain, blurred vision)
    • weak body
    • high fever
  • STOP USE

    Stop use and ask doctor if

    • nervousness, dizziness, or sleeplessness occur
    • pain, nasal congestion or cough gets worse or last more than 7 days
    • fever gets worse or lasts more than 3 days n redness or swelling is present
    • cough comes back or occurs with rash or headache that lasts

    These could be signs of a serious condition.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptom.

  • DOSAGE & ADMINISTRATION

    Directions

    • do not take more than directed (see overdose warning)
    Adults:Take 1 bottle (30mL) three times a day, 30 minutes after meal.
    Children and infants:Do not administer. Ask a doctor.

  • STORAGE AND HANDLING

    Other nformation

    • store at room temperature between 15°-25°C (59°-77°F) and avoid direct sunlight
  • INACTIVE INGREDIENTS

    • Inactive Ingredients: : alcohol, citric acid monohydrate, edetate disodium, fructooligosaccharide, lemon flavor, orange flavor, propylene glycol, sodium citrate, sucralose, water
  • PRINCIPAL DISPLAY PANEL

    PANCOLD A CASE (3 bottles x 30mL)

  • INGREDIENTS AND APPEARANCE
    PANCOLD A 
    acetaminophen, guaifenesin, pentoxyverine citrate, phenylpehrine hydcrochloride, chlorpheniramine maleate, caffeine anhydrous liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51352-189
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN80 mg  in 30 mL
    PENTOXYVERINE CITRATE (UNII: 4SH0MFJ5HJ) (PENTOXYVERINE - UNII:32C726X12W) PENTOXYVERINE CITRATE15 mg  in 30 mL
    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
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE30 mg  in 30 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CITRATE (UNII: 1Q73Q2JULR) 32.4 mg  in 30 mL
    SUCRALOSE (UNII: 96K6UQ3ZD4) 10 mg  in 30 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 29 mg  in 30 mL
    EDETATE DISODIUM (UNII: 7FLD91C86K) 3 mg  in 30 mL
    ALCOHOL (UNII: 3K9958V90M) 0.5 mL  in 30 mL
    SACCHARUM OFFICINARUM STEM FRUCTOOLIGOSACCHARIDES (UNII: 8LLD82AE3S) 7.5 g  in 30 mL
    WATER (UNII: 059QF0KO0R)  
    ORANGE (UNII: 5EVU04N5QU)  
    LEMON (UNII: 24RS0A988O)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorORANGE (Light yellowish clear oral liquid with orange-lemon flavor.) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51352-189-733 in 1 CASE07/01/2023
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:51352-189-755 in 1 CASE12/07/2023
    230 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/01/2023
    Labeler - DONGWHA PHARM. CO. LTD. (687745240)
    Registrant - DONGWHA PHARM. CO. LTD. (687745240)
    Establishment
    NameAddressID/FEIBusiness Operations
    DONGWHA PHARM. CO., LTD.687745240manufacture(51352-189)