DAY TIME NON-DROWSY COLD - FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [APTAPHARMA INC.]

DAY TIME NON-DROWSY COLD - FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [APTAPHARMA INC.]
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NDC 76281-506-28
Set ID c0dc613c-7f4e-4733-b2b6-6ba20e8fb83c
Category HUMAN OTC DRUG LABEL
Packager AptaPharma Inc.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients(in each 15 mL, 1 tablespoon)

    Acetaminophen               325 mg
    Dextromethorphan HBr 10 mg
    Phenylephrine HCI        5 mg

  • Purpose

    Pain reliever/fever reducer
    Cough suppressant
    Nasal decongestant

  • Uses

    temporarily relieves these common cold/flu symptoms:
    ■ minor aches and pains ■ headache ■ sore throat ■ fever
    ■ nasal congestion ■ cough due to minor throat and bronchial irritation

  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if ■ adult takes more than 4,000 mg of acetaminophen in 24 hours ■ child takes more than 5 doses in 24 hours ■ taken with other drugs containing acetaminophen ■ adult has 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.
    Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly

  • Do not use

    ■ 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 two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or a pharmacist before taking this product. ■ for more than 10 days for pain unless directed by a doctor. ■ for more than 3 days for fever unless directed by a doctor. ■ with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacists.

  • Ask a doctor before use if you have

    ■ liver disease ■ heart disease ■ thyroid disease ■ diabetes
    ■ high blood pressure ■ trouble urinating due to enlarged prostrate gland
    ■ persistent or chronic cough such as occurs with smoking, asthma, or
    emphysema ■ cough accompanied by excessive phlegm (mucus)

  • 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 (see overdose
    warning) ■ avoid alcoholic drinks

  • Stop use and ask a doctor if

    ■ you get nervous, dizzy or sleepless
    ■ new symptoms occur
    ■ fever gets worse or lasts more than 3 days
    ■ pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
    ■ redness or swelling is present
    ■ cough comes back or occurs with rash or headache that lasts.
    These couldbe signs of a serious condition.

  • If pregnant or breast-feeding

    ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of the reach of children.

  • Overdose Warning:

    Taking more than the recommended dose (overdose) may
    cause liver damage. 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.

  • Directions

    ■ take only as recommended (see overdose warning)
    ■ use dosage cup or tablespoon (TBSP)
    ■ do not exceed 4 doses per 24 hours

                         age                                                dose
    adults & children 12 years and over               30 mL (2 TBSP) every 4 hours
    children 6 to under 12 years                           15 mL (1 TBSP) every 4 hours
    children 4 to under 6 years                              ask a doctor
    children under 4 years                                     do not use

    When using Day Time and Night Time products, carefully read each label to
    ensure correct dosing.

  • Other information

    ■ sodium content per tablespoon: 10 mg
    ■ store at room temperature

  • Inactive Ingredients

    citric acid, FD&C Yellow # 6, Made in USA flavor, glycerin, propylene glycol, purified water,
    saccharin sodium, sodium benzoate, sucrose

  • Questions?

    Call weekdays from 9:30 AM to
    4:30 PM EST at 1-877-798-5944

  • Product Package Label

    NDC 76281-506-28

    AP SAFE

    *COMPARE TO
    the active ingredients in
    VICKS® DAYQUIL®

    Day Time

    Acetaminophen – Pain Reliever/Fever Reducer
    Dextromethorphan HBr – Cough Suppressant
    Phenylephrine HCI – Nasal Decongestant

    Non-Drowsy
    Cold & Flu Relief

    Multi-Symptom Relief

    12 FL OZ (354 mL)

    DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN
    Failure to follow these warnings could result in serious consequences

    Drug Facts

    Active Ingredients (in each 15 mL, 1 tablespoon)                     Purpose
    Acetaminophen 325 mg……………………………............…Pain reliever/fever reducer
    Dextromethorphan HBr 10 mg………………………….………Cough suppressant
    Phenylephrine HCI 5 mg………………………………………..Nasal decongestant

    Uses temporarily relieves these common cold/flu symptoms:
    ■ minor aches and pains ■ headache ■ sore throat ■ fever
    ■ nasal congestion ■ cough due to minor throat and bronchial irritation

    Warnings
    Liver warning: This product contains acetaminophen. Severe liver damage may occur if ■ adult takes more than 4,000 mg of acetaminophen in 24 hours ■ child takes more than 5 doses in 24 hours ■ taken with other drugs containing acetaminophen ■ adult has 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.
    Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly

    Do not use ■ 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 two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or a pharmacist before taking this product. ■ for more than 10 days for pain unless directed by a doctor. ■ for more than 3 days for fever unless directed by a doctor. ■ with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacists.

    Ask a doctor before use if you have
    ■ liver disease ■ heart disease ■ thyroid disease ■ diabetes
    ■ high blood pressure ■ trouble urinating due to enlarged prostrate gland
    ■ persistent or chronic cough such as occurs with smoking, asthma, or
    emphysema ■ cough accompanied by excessive phlegm (mucus)

    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 (see overdose
    warning) ■ avoid alcoholic drinks

    Stop use and ask a doctor if ■ you get nervous, dizzy or sleepless
    ■ new symptoms occur ■ fever gets worse or lasts more than 3 days ►

    Drug Facts (continued)

    ■ pain or cough gets worse or lasts more than 5 days (children) or 7 days
    (adults) ■ 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 this and all drugs out of the reach of children.

    Overdose Warning: Taking more than the recommended dose (overdose) may
    cause liver damage. 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.

    Directions ■ take only as recommended (see overdose warning)
    ■ use dosage cup or tablespoon (TBSP) ■ do not exceed 4 doses per 24 hours

                        age                                                dose
    adults & children 12 years and over               30 mL (2 TBSP) every 4 hours
    children 6 to under 12 years                         15 mL (1 TBSP) every 4 hours
    children 4 to under 6 years                           ask a doctor
    children under 4 years                                 do not use

    When using Day Time and Night Time products, carefully read each label to
    ensure correct dosing.

    Other information ■ sodium content per tablespoon: 10 mg
    ■ store at room temperature

    Inactive ingredients citric acid, FD&C Yellow # 6,                           Made in USA
    flavor, glycerin, propylene glycol, purified water,                                AP-LR-07
    saccharin sodium, sodium benzoate, sucrose

    Questions? Call weekdays from 9:30 AM to
    4:30 PM EST at 1-877-798-5944

    *This product is not manufactured or distributed by Procter &
    Gamble, owner of the registered trademark Vicks® DayQuil®.

    Manufactured by: AptaPharma Inc.,
    1533 Union Ave.
    Pennsauken, NJ 08110

               LOT:                                  EXP:

    DayTime NDCF

    6 OZ

    506 6oz label

    res

  • INGREDIENTS AND APPEARANCE
    DAY TIME NON-DROWSY COLD - FLU RELIEF 
    acetaminophen, dextromethorphan hbr, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76281-506
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) Acetaminophen325 mg  in 15 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 15 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE5 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76281-506-28354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2018
    2NDC:76281-506-25177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/2018
    Labeler - AptaPharma Inc. (790523323)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(76281-506) , pack(76281-506) , label(76281-506)

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