Zzzquil Capsule, Gelatin Coated
FDA Label NDC 37000-501

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Procter & Gamble Manufacturing Company for the product Zzzquil (NDC 37000-501). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients (in each liquicap), purpose, uses, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Dist. by Procter & Gamble, Cincinnati OH 45202.

Active Ingredients (In Each Liquicap)

Diphenhydramine HCl 25 mg

Purpose

nighttime sleep-aid

Uses

  • for the relief of occasional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep

Otc - Do Not Use

Do not use

  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin.

Otc - Ask Doctor

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Otc - When Using

When using this product

  • avoid alcoholic beverages

Otc - Stop Use

Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

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.

Directions

  • take only one dose per day (24 hours) - see Overdose warning

    • adults & children 12 yrs & over

    One dose = TWO 25 mg LiquiCaps (50 mg) at bed time if needed or as directed by a doctor

    children under 12 yrs

    do not use

Other Information

  • store at 20-25° C (68-77° F)
  • avoid excessive heat above 40° C (104° F)
  • protect from light.

Inactive Ingredients

FD&C Blue No. 1, FD&C Red No. 40, gelatin, glycerin, pharmaceutical ink*, polyethylene glycol, purified water, sorbitol sorbitan solution.
*May contain this ingredient.

Questions?

1-877-881-5813

Principal Display Panel - 12 Capsule Carton

NEW From the makers of VICKS ® NyQuil ®

ZzzQuil™

NIGHTTIME SLEEP-AID

Diphenhydramine HCl

Non-Habit Forming

See Warnings

Not for treating Cold or Flu

12 LiquiCaps

* Please review the disclaimer below.