Label: VICKS PAINQUIL AND VICKS PAINQUIL PM PAIN RELIEVER- acetaminophen, diphenhydramine hcl kit

  • NDC Code(s): 69423-833-12, 69423-834-12, 69423-849-24
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 7, 2024

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

  • SPL UNCLASSIFIED SECTION

    Vicks ® PainQuil™ PM PAIN RELIEVER + NIGHTTIME SLEEP-AID

    Drug Facts

  • Active ingredients (in each 30 mL)

    Acetaminophen 1000 mg

    Diphenhydramine HCl 50 mg

    Purpose

    Pain reliever

    Nighttime sleep-aid

  • Uses

    • for the temporary relief of occasional minor aches and pains with accompanying sleeplessness.
  • Warnings

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

    • more than 3 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product
    • 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

    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

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • for children under 12 years of age
    • with any other product containing diphenhydramine, even one used on skin
  • Ask a doctor before use if you have

    • liver disease
    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • difficulty in urination due to enlargement of the prostate gland
    • a sodium-restricted diet
  • Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers
  • Stop use and ask a doctor if

    • 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
    • sleeplessness persists continuously for more than 2 weeks.

    Insomnia may be a symptom of serious underlying medical illness.

    These could be signs of a serious condition.

  • When using this product

    • avoid alcoholic beverages
    • drowsiness will occur
    • do not drive a motor vehicle or operate machinery
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding,ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    • take only one dose (30 mL) per day (24 hours)
    • only use the dose cup provided
    • only use as directed
    adults & children 12 yrs & over30 mL at bedtime
    children under 12 yrsdo not use

  • Other information

    • each 30 mL contains: sodium 89 mg
    • do not exceed 25°C and do not refrigerate.
  • Inactive ingredients

    alcohol, anhydrous citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, polysorbate 20, propylene glycol, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, water, xanthan gum

  • Questions?

    1-877-881-5813

  • SPL UNCLASSIFIED SECTION

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

  • SPL UNCLASSIFIED SECTION

    DIST. BY: PROCTER & GAMBLE,

    CINCINNATI, OH 45202

  • SPL UNCLASSIFIED SECTION

    Vicks ® PainQuil™ PAIN RELIEVER

    Drug Facts

  • Active ingredients (in each 30 mL)

    Acetaminophen 1000 mg

    Purpose

    Pain reliever

  • Uses

    for the temporary relief of minor aches and pains associated with:

    • sore throat
    • headache
    • muscular aches
    • backache

  • Warnings

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

    • more than 3 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product
    • 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

    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

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • Ask a doctor before use if you have

    • liver disease
    • a sodium-restricted diet
  • Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin
  • Stop use and ask a doctor if

    • 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.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding,ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    In case of overdose, get medical help or contact a Poison Control Center right away. Quick 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 directed
    • do not exceed 3 doses (30 mL each) per day (24 hours)
    • only use the dose cup provided
    adults & children 12 yrs & over30 mL every 6 hours
    children under 12 yrsdo not use

  • Other information

    • each 30 mL contains: sodium 93 mg
    • do not exceed 25°C and do not refrigerate.
  • Inactive ingredients

    alcohol, anhydrous citric acid, FD&C Red No. 40, flavor, polysorbate 20, propylene glycol, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, water, xanthan gum

  • Questions?

    1-877-881-5813

  • SPL UNCLASSIFIED SECTION

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

  • SPL UNCLASSIFIED SECTION

    DIST. BY: PROCTER & GAMBLE,

    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - Convenience Pack

    Vicks ®PainQuil™ PAIN RELIEVER / Vicks ®PainQuil™ PM PAIN RELIEVER + NIGHTTIME SLEEP-AID
    MAX STRENGTH‡

    VALUE PACK

    ‡Maximum strength dose of active ingredients per dosing interval, only use as directed.

    Vicks ®PainQuil™ PAIN RELIEVER

    STARTS WORKING FAST FOR RELIEF OF:

    ACHES

    PAINS

    HEADACHE

    SORE THROAT

    BLACK CHERRY FLAVORED

    Alcohol 10%

    Vicks ®PainQuil™ PM PAIN RELIEVER + NIGHTTIME SLEEP-AID

    STARTS WORKING FAST FOR RELIEF OF:

    ACHES

    PAINS

    HEADACHE

    SORE THROAT

    +

    OCCASSIONAL SLEEPLESSNESS

    MIDNIGHT CHERRY FLAVORED

    Alcohol 10%

    2 BOTTLES - 1 PAINQUIL/1 PAINQUIL PM 12 FL OZ (354 mL) EACH; TOTAL 24 FL OZ (708 mL)

    convenience pack

  • INGREDIENTS AND APPEARANCE
    VICKS PAINQUIL AND VICKS PAINQUIL PM  PAIN RELIEVER
    acetaminophen, diphenhydramine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-849
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-849-241 in 1 PACKAGE; Type 0: Not a Combination Product05/07/2024
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 354 mL
    Part 21 BOTTLE 354 mL
    Part 1 of 2
    VICKS PAINQUIL  PAIN RELIEVER
    acetaminophen liquid
    Product Information
    Item Code (Source)NDC:69423-833
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN1000 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    WATER (UNII: 059QF0KO0R)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-833-12354 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01305/07/2024
    Part 2 of 2
    VICKS PAINQUIL PM  PAIN RELIEVER PLUS NIGHTTIME SLEEP-AID
    acetaminophen, diphenhydramine hcl liquid
    Product Information
    Item Code (Source)NDC:69423-834
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN1000 mg  in 30 mL
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    WATER (UNII: 059QF0KO0R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    Product Characteristics
    ColorpurpleScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-834-12354 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01005/07/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01305/07/2024
    Labeler - The Procter & Gamble Manufacturing Company (004238200)