Label: AMPIGRIN ULTRA FORTE NIGHT- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate 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.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each Softgels)Purpose
    Acetaminophen 325 mgPain reliever/fever reducer
    Dextromethorphan HBr 15 mgCough suppressant
    Doxylamine succinate 6.25 mgAntihistamine
  • Uses

    Temporarily relieves common cold/flu symptoms:

    • Cough due to minor throat & bronchial irritation
    • Sore throat
    • Headache
    • Minor aches & pains
    • Fever
    • Runny nose & sneezing
  • Warnings

    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. 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, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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
    • glaucoma
    • cough that occurs with too much phlegm (mucus)
    • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
    • trouble urinating due to enlarged prostate gland

    When using this product

    • Excitability may occur, especially in children
    • Marked drowsiness may occur
    • Avoid Alcoholic drinks
    • Be careful when driving a motor vehicle or operating machinery
    • Alcohol, sedatives, & tranquilizers may increase drowsiness

    Stop use and ask a doctor if

    • Pain or cough gets worse or lasts more than 7 days
    • Fever gets worse or lasts more than 3 days
    • Redness or swelling is present
    • New symptoms 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

    In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & 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 6 hrs
    Children 4 to under 12 yrsAsk a doctor
    Children under 4 yrsDo not use
  • Other information

    • Store at room temperature
  • Inactive ingredients

    D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, titanium dioxide

  • Questions?

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

  • SPL UNCLASSIFIED SECTION

    Made for:

    RRX



    Exclusively distributed by:

    OPMX

    Chula Vista, CA 91910

  • PRINCIPAL DISPLAY PANEL

    NDC 69729-003-10

    Ampigrin Ultra Forte

    Acetaminophen 325 mg Pain Reliever/Fever Reducer

    Dextromethorphan HBr 15 mg, Cough suppressant

    Doxylamine Succinate 6.25 mg Antihistamine

    COLD & COUGH

    • Cough Suppressant
    • Expectorant
    • Nasal Congestion
    • Sneezing
    • Itchy, Watery Eyes & Runny Nose
    • Descongestionante de las vías Respiratorias
    • Congestión Nasal
    • Estornudos
    • Comezon, Ojos llorosos y Escurrimiento Nasal

    10 Softgels

    Ampigrin_Ultra_Forte

  • INGREDIENTS AND APPEARANCE
    AMPIGRIN ULTRA FORTE NIGHT 
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    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
    ColorgreenScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code AP02
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69729-003-1010 in 1 CARTON06/10/2022
    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 DrugM01206/10/2022
    Labeler - OPMX LLC (029918743)
    Establishment
    NameAddressID/FEIBusiness Operations
    SOFTECH PHARMA PRIVATE LIMITED677111277label(69729-003) , manufacture(69729-003) , pack(69729-003)