Nighttime Sleep-aid Liquid
FDA Label NDC 53942-522

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Demoulas Market Basket for the product Nighttime Sleep-aid (NDC 53942-522). 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 active ingredientsdrug facts(in each 30 ml dose cup or 2 tablespoons), purpose, keep out of reach of children, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredientsdrug Facts(In Each 30 Ml Dose Cup Or 2 Tablespoons)

Diphenhydramine HCL 50 mg

Purpose

Nighttime sleep-aid

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.

Uses

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

Warnings

Do not use

  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
  • with any other drugs that cause drowsiness such as antihistamines and nighttime cough, cold/flu products

Ask A Doctor Before Use If You Have

  • heart disease
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a breathing problem such as asthma, emphysema or chronic bronchitis

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers or any other sleep aid

When Using This Product

  • do not use more than directed
  • avoid alcoholic beverages and other drugs that cause drowsiness
  • drowsiness will occur
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness

Stop Use And Ask A Doctor If

  • sleepiness persists continuously for more than two weeks. Insomnia may be a symptom of a serious underlying medical illness.

If Pregnant Or Breast Feeding

ask a health professional before use.

Other Information

  • each 30 mL dose (2 tablespoons) contains: sodium 23 mg
    • dosage cup provided
    • store at room temperature

Inactive Ingredients

citric acid, FD and C Blue # 1, FD and C Red # 40, flavor, high fructose corn syrup, poloxamer 407, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin

Questions?

Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

Directions

  • take only as recommended
  • use dosage cup or tablespoon

    • Age                                                              Dose
    Adults and children 12 years and over             One dose = 2 tablespoons (30 mL) at bedtime if needed or as directed by a doctor

Product Label

*COMPARE TO THE ACTIVE INGREDIENT IN ZzzQuil™ NIGHTTIME SLEEP-AID

Nighttime

SLEEP-AID

Diphenhydramine

Non-Habit Forming

Warming Berry Flavored Liquid

No for treating Cold or Flu

12 FL OZ (354 mL)

*This product is not manufactured or distributed by Proctor and Gamble, owner of the registered trademark ZzzQuil™ .

DISTRIBUTED BY DEMOULAS SUPERMARKETS INC.

875 EAST STREET

TEWKSBURY, MA 01876

LR-053 Rev 01

DO NOT USE IF IMPRINT SHRINK BAND IS MISSING OR BROKEN

Failure to follow these warnings could result in serious consequences

* Please review the disclaimer below.