Unisom Sleepmelts Nighttime Sleep-aid Tablet, Chewable
FDA Label NDC 41167-0014

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chattem, Inc. for the product Unisom Sleepmelts Nighttime Sleep-aid (NDC 41167-0014). 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 ingredient, purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

(in each caplet)

Diphenhydramine HCI 25 mg

Purpose

Nighttime sleep-aid

Uses

  • for relief of occasional sleeplessness

Do Not Use

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

Ask A Doctor Before Use If You Have

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

When Using This Product

avoid alcoholic drinks 

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.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • adults and children 12 years of age and over: 2 tablets (25 mg each) at bedtime if needed, or as directed by a doctor
  • place 2 tablets on tongue; tablets dissolve with or without water
  • allow tablets to dissolve in mouth or chew before swallowing

Inactive Ingredients

citric acid, ethylcellulose, flavor, hydroxypropyl cellulose, mannitol, microcrystalline cellulose, PVP, red 7, starch, sucralose, sucrose (309-154)

Dist. by: CHATTEM, Inc.
P.O. Box 2219, Chattanooga, TN 37409 USA
© 2011 Chattem Inc. www.chattem.com 

Principal Display Panel

Unisom®
SleepMeltsTM 
Diphenhydramine HCI tablets, 25 mg
NIGHTTIME SLEEP-AID
24 Tablets

Unisom®sleepmeltstm Diphenhydramine Hci Tablets, 25 mgnighttime Sleep-aid24 Tablets (Unisom Sleepmelts Nighttime Sleep Aid 01)

Unisom®sleepmeltstm Diphenhydramine Hci Tablets, 25 mgnighttime Sleep-aid24 Tablets (Unisom Sleepmelts Nighttime Sleep Aid 01)

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