Label: MULTI SYMPTOM SINUS RELIEF PAIN AND CONGESTION DAYTIME NIGHTTIME- acetaminophen, diphenhydramine hcl, guaifenesin, phenylephrine hcl kit

  • NDC Code(s): 70692-103-12
  • Packager: Strive Pharmaceuticals Inc.
  • 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 4, 2019

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

  • ACTIVE INGREDIENT

    Active ingredients (in each caplet) (Daytime)Purpose
    Acetaminophen 325mgPain Reliever
    Guaifenesin 200mgExpectorant
    Phenylephrine HCl 5mgNasal Decongestant
    Active ingredients (in each caplet) (Nighttime)Purpose
    Acetaminophen 325mgPain Reliever
    Diphenhydramine 12.5mgAnthistamine/Cough suppressant
    Phenylephrine HCl 5mgNasal Decongestant

  • PURPOSE

    Daytime

    Pain reliever, Expectorant and Nasal decongestant

    Nighttime

    Pain reliever, Antihistamine/cough suppressant and Nasal decongestant

  • INDICATIONS & USAGE

    * temporarily relieves:

    • nasal congestion
    • headache
    • minor aches and pain
    • sinus congestion and pressure
    • runny nose and sneezing (Nighttime only)
    • cough (Nighttime only)

    * temporarily promotes nasal and/or sinus drainag

    * helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (Daytime only)

  • WARNINGS

    Liver warning:
    This product contains acetaminophen. Severe liver damage may occur if you take:
    *more than 12 caplets in 24 hrs, which is the maximum daily amount
    * with other drugs containing acetaminophen
    *3 or more alcoholic drinks every day 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.

    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 have ever had an allergic reaction to this product or any of its ingredients
    * with any other drug containing diphenhydramine, even one used on the skin (Nighttime only)
    * 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
    * thyroid disease
    * trouble urinating due to an enlarged prostate gland
    * glaucoma (Nighttime only)
    * a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
    * persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
    * cough that occurs with too much phlegm (mucus)

    Ask a doctor or a pharmacist before use if you are
    * taking the blood thinning drug warfarin
    * taking sedatives or tranquilizers (Nighttime only)

    When using this product
    * do not exceed recommended dose
    * excitability may occur, especially in children (Nighttime only)
    * marked drowsiness may occur (Nighttime only)
    * alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
    * be careful when driving a motor vehicle or operating machinery (Nighttime only)
    * avoid alcoholic beverages (Nighttime only)

    Stop use and ask a doctor if
    * nervousness, dizziness, or sleeplessness occur
    * pain, nasal congestion, or cough gets worse or lasts more than 7 days
    * new symptoms occur
    * fever gets worse or lasts more than 3 days
    * redness or swelling is present
    * 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
    In case of accidental 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.


    If taking Nighttime and Daytime products,
    carefully read each section to ensure correct dosing
    Do not take DAYTIME and NIGHTTIME at the same time

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children
    In case of accidental 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
    * Do not use more than directed
    * swallow whole with a glass of water; do not crush, chew or dissolve
    * do not take more than 12 caplets in 24 hours

    adults and children 12 years of age and over

    take 2 caplets every 4 hours

    children under 12 years of age

    do not take

  • OTHER SAFETY INFORMATION

    Other information
    * each Nighttime caplet contains: Calcium 40mg or less
    * store at room temperature 25°C (77°F) ; excursions permitted between 15°C - 30°C (59°F -86°F)

  • INACTIVE INGREDIENT

    Inactive ingredients (Daytime)
    microcrystalline cellulose, dibasic calcium phosphate, croscarmellose sodium, talc, colloidal silicon dioxide, stearic acid, magnesium stearate, polyvinyl alcohol, polyethylene glycol, titanium dioxide,FD&C yellow #6, FD&C red #40, gelatin, starch, polyvinyl povidone, maltodextrin, sodium starch glycolate


    Inactive ingredients (Nightime)
    microcrystalline cellulose, dibasic calcium phosphate, corn starch, croscarmellose sodium, talc, colloidal silicon dioxide, stearic acid, magnesium stearate, polyvinyl alcohol, polyethylene glyocol, mica, titanium dioxide, FD&C blue #1, methacrylic acid copolymer, FD&C blue #2, sodium bicarbonate, starch, gelatin, sodium starch glycolate

  • PRINCIPAL DISPLAY PANEL

    CT103

  • INGREDIENTS AND APPEARANCE
    MULTI SYMPTOM SINUS RELIEF PAIN AND CONGESTION DAYTIME NIGHTTIME 
    acetaminophen, diphenhydramine hcl, guaifenesin, phenylephrine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70692-103
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70692-103-121 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product03/01/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BLISTER PACK
    Part 21 BLISTER PACK
    Part 1 of 2
    MULTI SYMPTOM SINUS RELIEF PAIN AND CONGESTION DAYTIME 
    acetaminophen, guaifenesin, phenylephrine hcl tablet, film coated
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    TALC (UNII: 7SEV7J4R1U)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    GELATIN (UNII: 2G86QN327L)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colororange (Reddish Orange) Scoreno score
    ShapeOVALSize19mm
    FlavorImprint Code S703
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/01/2018
    Part 2 of 2
    MULTI SYMPTOM SINUS RELIEF PAIN AND CONGESTION NIGHTTIME 
    acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride tablet, film coated
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    TALC (UNII: 7SEV7J4R1U)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, WHEAT (UNII: 79QS2MG2LP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    GELATIN (UNII: 2G86QN327L)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code S704
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/01/2018
    Labeler - Strive Pharmaceuticals Inc. (080028013)