Night Time Sleep-aid Liquid
FDA Label NDC 53943-522

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Discount Drug Mart for the product Night Time Sleep-aid (NDC 53943-522). 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 drug factsactive ingredients (in each 30 ml dose cup or 2 tablespoons), purpose, kep out of reach of children, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Factsactive Ingredients (In Each 30 Ml Dose Cup Or 2 Tablespoons)

Diphenhydramine HCL 50 mg

Purpose

Nighttime sleep-aid

Kep 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 IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN

Failure to follow these warnings could result in serious consequences.

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 driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness

Stop Use And Ask A Doctor If

sleeplessness persists continously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

If Pregnant Or Breast Feeding,

ask a health professional before use.

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
     Children under 12 years Do not 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, propllene 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

Discount Drug Mart Food Fair Night Time Sleep-Aid Product Label

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

DISCOUNT

drug mart

FOOD FAIR

NIGHT TIME SLEEP-AID

Diphenhydramine HCL

Non-Habit Forming

Warming Berry Flavored Liquid

Not 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™

LR-055

SATISFACTION GUARANTEED

IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO THE STORE WHERE PURCHASED. IF UNABLE TO RETURN TO THE STORE, SEND REASON FOR DISSATISFACTION , NAME, ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE MEDINNA, OHIO 44256

* Please review the disclaimer below.