Label: CHILDRENS COLTALIN- acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride tablet, chewable

  • NDC Code(s): 51467-006-01
  • Packager: FORTUNE PHARMACAL COMPANY LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 Label Information

Updated November 13, 2019

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

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)
    Acetaminophen 80 mg
    Chlorpheniramine maleate 0.5 mg
    Phenylephrine hydrochloride 1.25 mg

  • PURPOSE

    Purpose
    Pain reliever-fever reducer
    Antihistamine
    Nasal decongestant

  • INDICATIONS & USAGE

    Uses
    temporarily relieves these symptoms due to a cold, the flu, or hay fever:
    sore throat
    minor aches and pains
    headache
    itching of the nose or throat
    runny nose
    sneezing itchy, watery eyes due to hay fever
    sinus congestion and pressure
    nasal congestion
    temporarily reduces fever
    promotes nasal and/or sinus drainage

  • WARNINGS

    Warnings
    Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes: more than 5 doses in 24 hours, which the maximum daily amount for this product
    with other drugs containing acetaminophen

  • DO NOT USE

    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.
    in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease). If you do not know whether a prescription drug contains an MAOI, ask a doctor or pharmacist.
    for 2 weeks after stopping the MAOI drug

  • ASK DOCTOR

    Ask a doctor before use if the user has
    liver disease
    heart disease
    high blood pressure
    thyroid disease
    diabetes
    glaucoma
    a breathing problem such as chronic bronchitis

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if the user is
    taking the blood thinning drug warfarin
    taking sedatives or tranquilizers
    taking a prescription drug and you do not know if it contains an MAOI

  • WHEN USING

    When using this product
    do not exceed recommended dosage
    may cause drowsiness (sedatives and tranquilizers may increase the drowsiness effect)
    may cause excitability especially in children

  • STOP USE

    Stop use and ask a doctor if
    sore throat persists for more than 2 days
    sore throat is severe
    sore throat is accompanied or followed by: fever, headache, rash, nausea, vomitting
    pain or nasal congestion gets worse or lasts more than 5 day
    fever gets worse or lasts more than 3 days
    redness or swelling is presen
    new symptoms occur
    if nervousness, dizziness, or sleeplessness occur

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Do not give to children under 6 years of age unless directed by a doctor.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions
    children 6 to under 12 years of age: Chew tablet before swallowing. 4 tablets every 4 hours while symptoms persist, not to exceed 5 doses (20 tablets) in 24 hours, or as directed by a doctor
    children under 6 of age : consult a doctor

  • STORAGE AND HANDLING

    Other information
    Phenylketonurics: contains Phenylalanine 4.2mg per tablet
    protect from light
    store between 15 to 30 C (59 to 86 F)
    keep in a dry place

  • INACTIVE INGREDIENT

    Inactive ingredients
    Aspartame, citric acid, corn starch, FDC yellow no. 6 aluminum lake, magnesium stearate, mannitol, pineapple flavor, povidone K30

  • QUESTIONS

    Questions or comments? (888) 221-3496 M-F 9 am to 5 pm
    you may also use this number to report serious adverse events associated with the use of this product

  • PRINCIPAL DISPLAY PANEL

    Children's Coltalin

    NDC 51467-006-01

    Acetaminophen - Pain Reliever-Fever Reducer
    Chlorpheniramine maleate - Antihistamine
    Phenylephrine hydrochloride- Decongestant

    See new warnings information

    Sugar Free

    Aspirin Free

    24 Chewable Tablets

    Safety Sealed
    Do not use if individually sealed foil unit dose pouches are torn, broken, or shows the evidence of being opened.
    Box1

  • INGREDIENTS AND APPEARANCE
    CHILDRENS COLTALIN 
    acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51467-006
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN80 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE0.5 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE1.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    ASPARTAME (UNII: Z0H242BBR1)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    PINEAPPLE (UNII: 2A88ZO081O)  
    POVIDONE K30 (UNII: U725QWY32X)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize12mm
    FlavorPINEAPPLEImprint Code F;O;R;T;U;N;E
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51467-006-0124 in 1 CARTON; Type 1: Convenience Kit of Co-Package03/01/2004
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/01/2004
    Labeler - FORTUNE PHARMACAL COMPANY LIMITED (686280561)
    Establishment
    NameAddressID/FEIBusiness Operations
    FORTUNE PHARMACAL COMPANY LIMITED686280561manufacture(51467-006)