Vicks ®

Vicks ®
SPL v7
SPL
SPL Set ID f3bb75e8-3d43-f91e-e053-2a95a90a584d
Route
ORAL
Published
Effective Date 2023-03-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg) Acetaminophen (1000 mg)
Inactive Ingredients
Propylene Glycol Alcohol Citric Acid Monohydrate Polysorbate 20 Saccharin Sodium Water Fd&c Red No. 40 Sodium Benzoate Sodium Chloride Sodium Citrate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-03-03

Description

Drug Facts

Purpose

Pain reliever Nighttime sleep-aid


Medication Information

Purpose

Pain reliever

Nighttime sleep-aid

Description

Drug Facts

Uses
  • for the temporary relief of occasional minor aches and pains with accompanying sleeplessness.
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.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.

Section 50566-9

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
  • 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.

Section 50567-7

When using this product

  • avoid alcoholic beverages
  • drowsiness will occur
  • do not drive a motor vehicle or operate machinery
Section 50568-5

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
Section 50569-3

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
Section 50570-1

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.
Section 53414-9

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

Warnings

Liver warning: This product contains acetaminophen. Severe

liver damage may occur if you take

  • more than 4 doses (30 mL each) in 24 hours, which is the maimum 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

Directions
  • take only one dose (30 mL) per day (24 hours)
  • only use the dose cup provided
 adults & children 12 yrs & over  30 mL at bedtime
 children under 12 yrs  do not use

Questions?

1-877-881-5813

Other Information
  • each 30 mL contains:sodium 93 mg
  • store at no greater than 25° C and do not refrigerate
Inactive Ingredients

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

Active Ingredients (in Each 30 Ml)

Acetaminophen 1000 mg

Diphenhydramine HCl 50 mg

Principal Display Panel 354 Ml Bottle

VICKS ®

ZzzQuil



NIGHT PAIN



NIGHTTIME SLEEP-AID

PAIN RELIEVER



Diphenhydramine HCl

Acetaminophen

  • Fall Asleep Fast
  • Max Strength Pain Reliever
  • Non-Habit Forming

Black Cherry

Not For Colds

Alcohol 10%

12 FL OZ (354 ml)


Structured Label Content

Uses
  • for the temporary relief of occasional minor aches and pains with accompanying sleeplessness.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.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.

Section 50566-9 (50566-9)

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
  • 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.

Section 50567-7 (50567-7)

When using this product

  • avoid alcoholic beverages
  • drowsiness will occur
  • do not drive a motor vehicle or operate machinery
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
Section 50569-3 (50569-3)

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
Section 50570-1 (50570-1)

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.
Section 53414-9 (53414-9)

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

Purpose

Pain reliever

Nighttime sleep-aid

Warnings

Liver warning: This product contains acetaminophen. Severe

liver damage may occur if you take

  • more than 4 doses (30 mL each) in 24 hours, which is the maimum 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

Directions
  • take only one dose (30 mL) per day (24 hours)
  • only use the dose cup provided
 adults & children 12 yrs & over  30 mL at bedtime
 children under 12 yrs  do not use

Questions?

1-877-881-5813

Other Information (Other information)
  • each 30 mL contains:sodium 93 mg
  • store at no greater than 25° C and do not refrigerate
Inactive Ingredients (Inactive ingredients)

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

Active Ingredients (in Each 30 Ml) (Active ingredients (in each 30 mL))

Acetaminophen 1000 mg

Diphenhydramine HCl 50 mg

Principal Display Panel 354 Ml Bottle (PRINCIPAL DISPLAY PANEL - 354 ml bottle)

VICKS ®

ZzzQuil



NIGHT PAIN



NIGHTTIME SLEEP-AID

PAIN RELIEVER



Diphenhydramine HCl

Acetaminophen

  • Fall Asleep Fast
  • Max Strength Pain Reliever
  • Non-Habit Forming

Black Cherry

Not For Colds

Alcohol 10%

12 FL OZ (354 ml)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)