NDC 37000-975 Vicks Zzzquil Night Pain

Diphenhydramine Hydrochloride And Acetaminophen

NDC Product Code 37000-975

NDC 37000-975-12

Package Description: 354 mL in 1 BOTTLE

NDC 37000-975-24

Package Description: 2 BOTTLE in 1 CELLO PACK > 354 mL in 1 BOTTLE

NDC Product Information

Vicks Zzzquil Night Pain with NDC 37000-975 is a a human over the counter drug product labeled by The Procter & Gamble Manufacturing Company. The generic name of Vicks Zzzquil Night Pain is diphenhydramine hydrochloride and acetaminophen. The product's dosage form is liquid and is administered via oral form.

Labeler Name: The Procter & Gamble Manufacturing Company

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Vicks Zzzquil Night Pain Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL
  • ACETAMINOPHEN 1000 mg/30mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • ALCOHOL (UNII: 3K9958V90M)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • WATER (UNII: 059QF0KO0R)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • SORBITOL (UNII: 506T60A25R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • XANTHAN GUM (UNII: TTV12P4NEE)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: The Procter & Gamble Manufacturing Company
Labeler Code: 37000
FDA Application Number: part343 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 06-01-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Vicks Zzzquil Night Pain Product Label Images

Vicks Zzzquil Night Pain Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

DIST. BY PROCTER & GAMBLE,CINCINNATI, OH 45202

Active Ingredients (In Each 30 Ml)

Acetaminophen 1000 mgDiphenhydramine HCl 50 mg

Purpose

Pain relieverNighttime 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• adult takes more than 4 doses (30 mL each) in 24 hrs, whichis the maximum daily amount for this product• taken with other drugs containing acetaminophen• 3 or more alcoholic drinks every day while using this productAllergy Alert: Acetaminophen may cause severe skin reactions.
Symptoms may include: • skin reddening • blisters • rashIf a skin reaction occurs, stop use and seek medical help right away

Otc - Do Not Use

  • 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 agewith any other product containing diphenhydramine, even one used on skin.

Otc - Ask Doctor

  • Ask a doctor before use if you have liver diseasea breathing problem such as emphysema or chronic bronchitisglaucomadifficulty in urination due to enlargement of the prostate glanda sodium-restricted diet

Otc - Ask Doctor/Pharmacist

  • Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarintaking sedatives or tranquilizers

Otc - When Using

  • When using this product avoid alcoholic beveragesdrowsiness will occurdo not drive a motor vehicle or operate machinery

Otc - Stop Use

  • Stop use and ask a doctor if pain gets worse or lasts more than 10 daysfever gets worse or lasts more than 3 daysnew symptoms occursleeplessness 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.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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.

Directions

  • Take only 1 dise (30 mL) per day (24 hours)adults & children 12 yrs & over30 mL at bedtimechildren under 12 yrsdo not use

Other Information

  • Each 30 mL contains: sodium 151 mgstore at no greater than 25° C and do not refrigerate

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.

Questions?

1-877-881-5813

* Please review the disclaimer below.