Vicks ZzzQuil NIGHT PAIN NIGHTTIME SLEEP-AID PAIN RELIEVER — v15

Vicks ZzzQuil NIGHT PAIN NIGHTTIME SLEEP-AID PAIN RELIEVER

8 Views

Version

v15

Effective date

October 1, 2025

Original packager

Yes

Sections captured

19

Identifiers

Document ID
401e3ec8-c34b-8390-e063-6394a90a9ec6
Set ID
065d760b-70a5-3e26-e063-6394a90a48cd
Application numbers
M010
Product NDCs
37000-598
Package NDCs
37000-598-12, 37000-598-24
Original packager NDCs

Names & Manufacturers

Brand names
Vicks ZzzQuil NIGHT PAIN NIGHTTIME SLEEP-AID PAIN RELIEVER
Generic names
DIPHENHYDRAMINE HCL, ACETAMINOPHEN
Manufacturer names
The Procter & Gamble Manufacturing Company
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Routes
ORAL
Pharmacologic class (PE)
Pharmacologic class (EPC)
Pharmacologic class (CS)
Mechanism of action

Other identifiers

NUI
RxCUI
1092373
UNII
362O9ITL9D, TC2D6JAD40
UPC

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredients (in each 30 mL) Acetaminophen 1000 mg Diphenhydramine HCl 50 mg
Ask Doctor (1)

Sequence 1

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 Doctor Or Pharmacist (1)

Sequence 1

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers
Dosage And Administration (1)

Sequence 1

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
Dosage And Administration Table (1)

Sequence 1

adults & children 12 yrs & over30 mL at bedtime
children under 12 yrsdo not use
Inactive Ingredient (1)

Sequence 1

Inactive ingredients alcohol, citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavors, polysorbate 20, propylene glycol, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, water, xanthan gum.
Indications And Usage (1)

Sequence 1

Use for the temporary relief of occasional minor aches and pains with accompanying sleeplessness.
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children.
Overdosage (1)

Sequence 1

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.
Package Label Principal Display Panel (1)

Sequence 1

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 Midnight Berry Not for colds Alcohol 10% 12 FL OZ (354 ml) 598
Pregnancy Or Breast Feeding (1)

Sequence 1

If pregnant or breast-feeding , ask a health professional before use.
Purpose (1)

Sequence 1

Purpose Pain reliever Nighttime sleep-aid
Questions (1)

Sequence 1

Questions? 1-877-881-5813
Spl Product Data Elements (1)

Sequence 1

Vicks ZzzQuil NIGHT PAIN NIGHTTIME SLEEP-AID PAIN RELIEVER Diphenhydramine HCl, Acetaminophen ALCOHOL PROPYLENE GLYCOL FD&C BLUE NO. 1 CITRIC ACID MONOHYDRATE POLYSORBATE 20 SACCHARIN SODIUM WATER FD&C RED NO. 40 SODIUM BENZOATE SODIUM CHLORIDE SODIUM CITRATE SORBITOL SUCRALOSE XANTHAN GUM DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ACETAMINOPHEN ACETAMINOPHEN
Spl Unclassified Section (3)

Sequence 1

Drug Facts

Sequence 2

Tamper Evident : Do not use if printed shrinkband seal around the neck is broken or missing.

Sequence 3

DIST. BY PROCTER & GAMBLE, CINCINNATI, OH 45202
Stop Use (1)

Sequence 1

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.
Storage And Handling (1)

Sequence 1

Other information each 30 mL contains: sodium 151 mg store at no greater than 25°C and do not refrigerate
Warnings (1)

Sequence 1

Warnings Liver warning : This product contains acetaminophen. Severe liver damage may occur if you take • more than 4 doses (30 mL each) in 24 hrs, 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 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
When Using (1)

Sequence 1

When using this product avoid alcoholic beverages drowsiness will occur do not drive a motor vehicle or operate machinery

OpenFDA raw payload

{'application_number': ['M010'],
 'brand_name': ['Vicks ZzzQuil NIGHT PAIN NIGHTTIME SLEEP-AID PAIN RELIEVER'],
 'generic_name': ['DIPHENHYDRAMINE HCL, ACETAMINOPHEN'],
 'is_original_packager': [True],
 'manufacturer_name': ['The Procter & Gamble Manufacturing Company'],
 'package_ndc': ['37000-598-12', '37000-598-24'],
 'product_ndc': ['37000-598'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['ORAL'],
 'rxcui': ['1092373'],
 'spl_id': ['401e3ec8-c34b-8390-e063-6394a90a9ec6'],
 'spl_set_id': ['065d760b-70a5-3e26-e063-6394a90a48cd'],
 'substance_name': ['ACETAMINOPHEN', 'DIPHENHYDRAMINE HYDROCHLORIDE'],
 'unii': ['362O9ITL9D', 'TC2D6JAD40']}