EXTRA FAST COLTALIN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET [FORTUNE PHARMACAL COMPANY LIMITED]

EXTRA FAST COLTALIN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET [FORTUNE PHARMACAL COMPANY LIMITED]
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NDC 51467-010-01, 51467-010-02
Set ID ec1e59a0-bcad-49f0-b731-d15445d99370
Category HUMAN OTC DRUG LABEL
Packager FORTUNE PHARMACAL COMPANY LIMITED
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)
    Acetaminophen 325 mg
    Chlorpheniramine maleate 2 mg
    Phenylephrine hydrochloride 5 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:
       ■ minor aches and pains
       ■ sore throat
       ■ headache
       ■ runny nose
       ■ sinus congestion and pressure
       ■ nasal congestion due to a cold or hay fever
       ■ runny nose
       ■ sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever
    ■ temporarily reduces fever
    ■ promotes nasal and/or sinus drainage

  • WARNINGS

    Warnings
    Liver warning: This product contains acetaminophen. Severe liver damage may occur if:
    ■ adult takes more than 12 tablets in 24 hours, which the maximum daily amount for this product
    ■ child takes more than 5 doses in 24 hours
    ■ taken with other drugs containing acetaminophen
    ■ adult has 3 or more alcoholic drinks everyday while using this product

  • 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.
    ■ if you are now 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 whether a prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

  • ASK DOCTOR

    Ask a doctor before use if the user has
    ■ heart disease
    ■ high blood pressure
    ■ diabetes
    ■ glaucoma
    ■ liver disease
    ■ thyroid disease
    ■ a high fever
    ■ a breathing problem such as emphysema or chronic bronchitis
    ■ difficulty in urination due to enlargement of the prostate gland

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if the user is
    ■ taking tranquilizers or sedatives
    ■ taking the blood thinning drug warfarin

  • WHEN USING

    When using this product
    do not exceed recommended dosage
    ■ may cause excitability especially in children
    ■ use caution when driving or operating machinery
    ■ avoid alcoholic beverages
    ■ may cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect

  • STOP USE

    Stop use and ask a doctor if
    ■ pain or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults)
    ■ sore throat persists for more than 2 days
    ■ fever gets worse or lasts more than 3 days
    ■ nasal congestion is accompanied by fever
    ■ nervousness, dizziness, or sleeplessness occur
    ■ redness or swelling is present
    ■ new symptoms occur
    ■ any of the following occurs (these could be signs of a serious condition):
       ■ severe sore throat
       ■ sore throat is accompanied or followed by fever, headache, rash, nausea or vomiting

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

  • 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. 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
    ■ adults and children 12 years of age and over: 2 tablets every 4 hours, while symptoms persist, not to exceed 6 doses (12 tablets) in 24 hours, or as directed by a doctor
    ■ children 6 to under 12 years of age: 1 tablet every 4 hours, while symptoms persist, not to exceed 5 doses (5 tablets) in 24 hours, or as directed by a doctor
    ■ children under 6 of age : consult a doctor

  • STORAGE AND HANDLING

    Other information
    ■ keep tightly sealed
    ■ store between below 25 C (77 F) in a dry place, away from direct sunlight

  • INACTIVE INGREDIENT

    Inactive ingredients
    colloidal silicon dioxide, corn starch, FD C yellow no. 6 aluminum lake, magnesium stearate, povidone K30, sodium starch glycolate

  • 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

    EXTRA FAST COLTALIN

    Safely Sealed

    NDC 51467-010-01

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

    Cold, Flu & Hay Fever Multi-Symptom Relief
    ■ Minor Aches & Pain, Sore Throat
    ■ Headache, Fever
    ■ Nasal Congestion, Sinus Pressure/Drainage
    ■ Sneezing, Runny Nose
    ■ Itchy, Watery Eyes

    24 Tablets

    In Individually Sealed Strip

    Aspirin Free
    IMAGE OF 24 TABLET BOX

  • PRINCIPAL DISPLAY PANEL

    EXTRA FAST COLTALIN

    Safely Sealed

    NDC 51467-010-02

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

    Cold, Flu & Hay Fever Multi-Symptom Relief
    ■ Minor Aches & Pain, Sore Throat
    ■ Headache, Fever
    ■ Nasal Congestion, Sinus Pressure/Drainage
    ■ Sneezing, Runny Nose
    ■ Itchy, Watery Eyes

    36 Tablets

    In Individually Sealed Strip

    Aspirin Free
    IMAGE OF 36 TABLET BOX

  • INGREDIENTS AND APPEARANCE
    EXTRA FAST COLTALIN 
    acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51467-010
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code COLTALIN
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51467-010-012 in 1 BOX04/04/2017
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:51467-010-023 in 1 BOX04/04/2017
    212 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/04/2017
    Labeler - FORTUNE PHARMACAL COMPANY LIMITED (686280561)
    Establishment
    NameAddressID/FEIBusiness Operations
    FORTUNE PHARMACAL COMPANY LIMITED686280561manufacture(51467-010)

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