Premier Value Nighttime Sleep Aid Softgels
FDA Label NDC 68016-218

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Consortium for the product Premier Value Nighttime Sleep Aid Softgels (NDC 68016-218). 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 softgel), 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

Failure to follow these warnings could result in serious consequences

TAMPER EVIDENT: This package is safety sealed & child resistant. Use only if blisters are intact. If difficult to open, use scissors.

Distributed by:

Chain Drug Consortium LLC.

3301 N.W. Boca Raton Blvd.

Suite 101, Boca Raton FL 33431

*This product is not manufactured or distributed by Procter & Gamble, the distributor of ZzzQuil® Liquicaps.

Active Ingredients (In Each Softgel)

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.
  • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

Otc - Ask Doctor

Ask a doctor before use if you have

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

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep aid

Otc - When Using

When using this product

  • avoid alcoholic beverages and other drugs that cause drowsiness
  • drowsiness will occur
  • be careful when driving a motor vehicle or operating machinery

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. Overdose warning: Taking more than directed can cause serious health problems. 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 Softgels (50 mg)
    at bed time if needed or as directed by a doctor

Other Information

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

Inactive Ingredients

FD&C blue 1, FD&C red 40, gelatin, glycerin, methylparaben, polyethylene glycol, propylparaben, purified water, sorbitol, titanium dioxide

Principal Display Panel

Premier Value
Nighttime

Sleep-Aid Softgels
Diphenhydramine HCl

Non Habit Forming

Not for treating Cold or Flu

See Warnings

Compare to ZzzQuil® Liquicaps® active ingredient*

24 SOFTGELS

Premier Value Nighttime Sleep-aid Softgel (Image 01)

Premier Value Nighttime Sleep-aid Softgel (Image 01)

* Please review the disclaimer below.