DAYTIME AND NIGHTTIME PAIN RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [CVS PHARMACY, INC.]

DAYTIME AND NIGHTTIME PAIN RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [CVS PHARMACY, INC.]
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NDC 69842-002-35, 69842-003-20, 69842-004-20
Set ID b5265dc4-ec50-4257-a2df-2e7dd54c58c8
Category Human OTC Drug Label
Packager CVS Pharmacy, Inc.
Generic Name
Product Class
Product Number
Application Number PART343
  • Drug Facts - Day Time

    Active ingredient (in each 15 mL)

    Acetaminophen USP 500 mg

  • Drug Facts - Night Time

    Active ingredients (in each 15 mL)

    Acetaminophen USP 500 mg

    Diphenhydramine HCl USP 25 mg

  • Purpose - Day Time

    Pain reliever/Fever reducer

  • Purpose - Night Time

    Pain reliever
    Nighttime Sleep Aid

  • Uses - Day Time

    • temporarily relieves minor aches and pains due to:
    • headache
    • muscular aches
    • backache
    • minor pain of arthritis
    • the common cold
    • toothache
    • premenstrual and menstrual cramps
    • temporarily reduces fever
  • Uses - Night Time

    Temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

  • Warnings - Day Time

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

    • more than 4 doses (120 mL) in 24 hours, 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.

  • Warnings - Night Time

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

    • more than 4,000 mg of acetaminophen in 24 hours
    • 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 - Day Time

    • with any other drug containing acetaminophen (prescription or non-prescription). 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
  • Do not use - Night Time

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • with any other product containing diphenhydramine, even one used on skin
    • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
    • for children under 12 years of age
    • if you have ever had an allergic reaction to this product or any of its ingredients
  • Ask a doctor before use if you have - Day Time

    liver disease

  • Ask a doctor before use if you have - Night Time

    • liver disease
    • a breathing problem such as emphysema or chronic bronchitis
    • trouble urinating due to an enlarged prostate gland
    • glaucoma
  • Ask a doctor or pharmacist before use if you are - Day Time

    taking the blood thinning drug warfarin

  • Ask a doctor or pharmacist before use if you are - Night Time

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers or any other sleep aid
  • When using this product - Night Time

    • drowsiness will occur
    • avoid alcoholic drinks
    • do not drive a motor vehicle or operate machinery
  • Stop use and ask a doctor if - Day Time

    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • new symptoms occur
    • redness or swelling is present

    These could be signs of a serious condition.

  • Stop use and ask a doctor if - Night Time

    • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
    • Pain gets worse or lasts more than 10 days
    • Fever gets worse or lasts more than 3 days
    • Redness or swelling is present
    • New symptoms occur

    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. - Day Time

    Overdose warning

    Taking more than the recommended dose (overdose) may cause liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center (1-800-222-1222) immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Keep out of reach of children. - Night Time

    Overdose warning:

    Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions - Day Time

    • do not take more than directed (see overdose warning)
    • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
    • mL=milliliter; Tbsp= Tablespoon
    • adults and children 12 years and over: take 30 mL (2 Tbsp) in dose cup provided every 4 to 6 hours while symptoms last. Do not take more than 120 mL (8 Tbsp) in 24 hours. Do not take more than 10 days unless directed by a doctor.
    • children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.
  • Directions - Night Time

    • do not take more than directed (see overdose warning)
    • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
    • mL=milliliter; Tbsp= Tablespoon
    • adults and children 12 years and over: take 30 mL (2 Tbsp) at bedtime. Do not take more than 30 mL (2 Tbsp) in 24 hours.
    • children under 12 years: do not use
  • Other information - Day Time

    • each 15 mL (1 Tbsp) contains: sodium 7 mg
    • store at 20-25° C (68-77° F).
    • dosage cup provided
  • Other information - Night Time

    • each 15 mL (1 Tbsp) contains: sodium 9 mg
    • store at 20-25°C (68-77°F). Do not refrigerate.
  • Inactive ingredients - Day Time

    anhydrous citric acid, carboxymethylcellulose sodium, D&C Red 33, FD&C red 40,flavors, high fructose corn syrup, non-crystallizing sorbitol solution, polyethylene glycol, propylene glycol, purified water, sodium benzoate, and sucralose.

  • Inactive ingredients - Night Time

    anhydrous citric acid, FD&C Blue no.1, FD&C Green no. 3, flavors, high fructose corn syrup, menthol, non-crystallizing sorbitol solution, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium carboxymethylcellulose, and sucralose.

  • Questions or comments?

    1-855-274-4122

    TAMPER EVIDENT: DO NOT USE IF PRINTED SHRINKBAND IS MISSING OR BROKEN

    DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive
    Woonsocket, RI 02895
    © 2016 CVS/pharmacy
    CVS.com®
    1-800-SHOP CVS
    V-31869

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 16 FL OZ (474 mL Bottle)

    CVS

    HealthTM

    Compare to the active ingredients in Tylenol®

    Extra Strength Adult Rapid Blast Cherry*


    NDC 69842-002-35

    EXTRA STRENGTH

    Daytime
    Pain Relief
    ACETAMINOPHEN 500 mg
    Pain reliever; Fever reducer
    Non-drowsy

    Cherry Flavor
    Rapid Burst

    Nighttime
    Pain Relief
    ACETAMINOPHEN 500 mg
    Pain reliever
    DIPHENHYDRAMINE HCl 25 mg
    Nighttime sleep aid
    Alcohol free

    Berry Flavor

    TWO 8 FL OZ (237 mL) BOTTLES
    TOTAL - 16 FL OZ (474 mL)

    See Warnings Information

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 16 FL OZ (474 mL Bottle)

  • INGREDIENTS AND APPEARANCE
    DAYTIME AND NIGHTTIME PAIN RELIEF 
    acetaminophen, diphenhydramine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-002
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-002-351 in 1 CARTON; Type 0: Not a Combination Product12/09/201507/01/2022
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 237 mL
    Part 21 BOTTLE 237 mL
    Part 1 of 2
    DAYTIME PAIN RELIEF 
    pain reliever/fever reducer liquid
    Product Information
    Item Code (Source)NDC:69842-003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    CHERRY (UNII: BUC5I9595W)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    SORBITOL (UNII: 506T60A25R)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorCHERRY, MENTHOLImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-003-201 in 1 CARTON
    1237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34312/09/201507/01/2022
    Part 2 of 2
    NIGHTTIME PAIN RELIEF 
    pain reliever/nighttime sleep aid liquid
    Product Information
    Item Code (Source)NDC:69842-004
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg  in 15 mL
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    SORBITOL (UNII: 506T60A25R)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorBLUE (blue to bluish green) Score    
    ShapeSize
    FlavorBERRY, PEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-004-201 in 1 CARTON
    1237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34312/09/201507/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34312/09/201507/01/2022
    Labeler - CVS Pharmacy, Inc. (062312574)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurohealth LLC078728447MANUFACTURE(69842-002)

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