Label: DAYTIME AND NIGHTTIME PAIN RELIEF- acetaminophen, diphenhydramine hcl kit

  • NDC Code(s): 69842-002-35, 69842-003-20, 69842-004-20
  • Packager: CVS Pharmacy, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 December 10, 2020

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

  • 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)