Label: ACTIVCIN- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 5, 2024

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

  • ACTIVE INGREDIENT

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each LiquiCap)Purpose
    Acetaminophen 325 mgPain reliever/fever reducer
    Dextromethorphan HBr 10 mgCough suppressant
    Phenylephrine HCl 5 mgNasal decongestant
  • Uses

    Temporarily relieves common cold/flu symptoms:

    • Nasal congestion
    • Cough due to minor throat & bronchial irritation
    • Sore throat
    • Headache
    • Minor aches & pains
    • Fever
  • Warnings

    Liver warning

    Liver warning

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

    • more than 4 doses in 24 hrs, which is the maximum daily amount for this product
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks daily while using this product

    Allergy alert

    Acetaminophen may cause severe skin reactions. Symtoms 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, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

    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 if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    • Liver disease
    • Heart disease
    • Diabetes
    • High blood pressure
    • Trouble urinating due to enlarged prostate gland
    • Cough that occurs with too much phlegm (mucus)
    • Persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis or emphysema.

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

    When using this product,

    do not use more than directed.

    Stop use and ask a doctor if

    • You get nervouz, dizzy or sleepless.
    • Symptoms get worse or last more than 5 days (children) or 7 days (adults).
    • Fever gets worse or lasts more than 3 days.
    • Redness or swelling is present.
    • New symtoms occur.
    • Cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    Overdose warning

    Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well for children even if you do not notice any signs or symptoms.

  • Directions

    • Take only as directed.
    • Do not exceed 4 doses per 24 hrs.
    Adults & children 12 yrs & over2 softgels with water every 4 hrs
    Children 4 to under 12 yrsAsk a doctor
    Children under 4 yrsDo not use
  • Other information

    Store at room temperature

  • Inactive ingredients

    FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, titanium dioxide.

  • Questions?

    Call to free 619-600-5632 Monday through Friday 9AM - 5PM EST

  • SPL UNCLASSIFIED SECTION

    Made for:

    RRX

    Exclusively distributed by:

    OPMX

    Chula Vista, CA 91910

    Phone: 619-600-5632

  • PRINCIPAL DISPLAY PANEL

    NDC 69729-008-10

    COUGH & FLU / TOS Y GRIPE

    Activsin

    Day-TimeRelief

    Non-Drowsy Multi-Symptom Relief

    Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl

    • Body Aches / Dolor de cuerpo
    • Fever / Fiebre
    • Sore throat / Dolor de cabeza
    • Nasal Congestion / Congestion Nasal
    • Cough / Tos

    10 Softgels / 10 Cápsulas blandas de gel

    Activcin

  • INGREDIENTS AND APPEARANCE
    ACTIVCIN 
    acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-008
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code AP01
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69729-008-101 in 1 CARTON05/23/2022
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/23/2022
    Labeler - OPMX LLC. (029918743)
    Establishment
    NameAddressID/FEIBusiness Operations
    SOFTECH PHARMA PRIVATE LIMITED677111277label(69729-008) , manufacture(69729-008) , pack(69729-008)