Label: COLTALIN-DM- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride tablet

  • NDC Code(s): 51467-007-01, 51467-007-02
  • 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 February 22, 2021

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

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)
    Acetaminophen 325 mg
    Chlorpheniramine maleate 2 mg
    Dextromethorphan hydrobromide 10 mg
    Phenylephrine hydrochloride 5 mg

  • PURPOSE

    Purpose​s
    Pain reliever-fever reducer
    Antihistamine
    Cough suppressant
    Nasal decongestant

  • INDICATIONS & USAGE

    Uses
    ■ temporarily relieves these symptoms due to a cold, the flu, or hay fever:
       ■ minor aches and pains
       ■ headache
       ■ sore throat
       ■ nasal congestion
       ■ runny nose
       ■ sinus congestion and pressure
       ■ cough due to minor throat and bronchial irritation
       ■ 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 is 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 the user is 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 if your 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
    ■ a persistent cough

  • ASK DOCTOR/PHARMACIST

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

  • WHEN USING

    When using this product
    ■ do not exceed recommended dosage
    ■ may cause excitability especially in children
    ■ do not drive or operate machinery
    ■ avoid alcoholic beverages
    ■ may cause marked 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
    ■ nasal congestion is accompanied by fever
    ■ nervousness, dizziness, or sleeplessness occur
    ■ any of the following occurs (these could be signs of a serious condition):
       ■ fever gets worse or lasts more than 3 days
       ■ a severe sore throat
       ■ sore throat is accompanied or followed by fever, headache, rash, nausea or vomiting
       ■ redness or swelling is present
       ■ new symptoms occur
       ■ cough persists for more than 1 week, tends to recur, or is accompanied by fever rash, or persistent headache

    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 for 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, D&C yellow no. 10 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 report serious side effects to this phone number

  • PRINCIPAL DISPLAY PANEL

    COLTALIN-DM

    Safely Sealed

    NDC 51467-007-01

    Acetaminophen - Pain Reliever-Fever Reducer
    Chlorpheniramine Maleate - Antihistamine
    Dextromethorphan Hydrobromide - Cough Suppressant
    Phenylephrine Hydrochloride - Nasal Decongestant

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

    24 Tablets

    In Individually Sealed Strip

    Aspirin Free
    IMAGE OF 24 TABLETS BOX

  • PRINCIPAL DISPLAY PANEL

    COLTALIN-DM

    Safely Sealed

    NDC 51467-007-02

    Acetaminophen - Pain Reliever-Fever Reducer
    Chlorpheniramine Maleate - Antihistamine
    Dextromethorphan Hydrobromide - Cough Suppressant
    Phenylephrine Hydrochloride - Nasal Decongestant

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

    36 Tablets

    In Individually Sealed Strip

    Aspirin Free

    IMAGE OF 36 TABLETS BOX

  • INGREDIENTS AND APPEARANCE
    COLTALIN-DM 
    acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51467-007
    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
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code FORTUNE
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51467-007-012 in 1 BOX03/01/2004
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:51467-007-023 in 1 BOX04/26/2016
    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 finalpart34103/01/2004
    Labeler - FORTUNE PHARMACAL COMPANY LIMITED (686280561)
    Establishment
    NameAddressID/FEIBusiness Operations
    FORTUNE PHARMACAL COMPANY LIMITED686280561manufacture(51467-007)