Night Time Sleep-aid Tablet
FDA Label NDC 80513-383

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Advanced Rx Llc for the product Night Time Sleep-aid (NDC 80513-383). 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 caplet), 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

Distributed by:

Advanced Rx LLC

1942 NE 163rd St North Miami Beach,

FL 33162 U.S.A.

MADE IN THE USA

Active Ingredients (In Each Caplet)

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 (2 Caplets) per day (24 hours)

adults & children 12 yrs & over2 Caplets at bedtime if needed or as directed by a doctor
children under 12 yrsdo not use

Other Information

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • read all product information before using
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSIN

Inactive Ingredients

Microcrystalline Cellulose, Dicalcium Phosphate, Stearic Acid, Croscarmellose Sodium, Colloidal Silicon Dioxide, Hypromellose, Titanium Dioxide, Triacetin, FD&C Red No.40 Lake, FD&C Blue No.2 Aluminum Lake, Polysorbate.

Questions Or Comments

Call toll free 1-800-630-8895

Monday through Friday 9AM - 5PM EST

Principal Display Panel

NDC 80513-383-22

Compare to the  active indredient in VICKS ®ZzzQuil ®NIGHTTIME SLEEP-AID*

NIGHT TIME SLEEP-AID

Diphenhydramine HCl 25 mg

220 CAPLETS

*This product is not manufactured or distributed by The The Procter & Gamble Company, owner of the registered trademark VICKS ®ZzzQuil ®NIGHTTIME SLEEP-AID

Label (Label)

Label (Label)

* Please review the disclaimer below.