FDA Label for Unisom Sleepmelts Nighttime Sleep-aid
View Indications, Usage & Precautions
- OTHER
- 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
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Unisom Sleepmelts Nighttime Sleep-aid Product Label
The following document was submitted to the FDA by the labeler of this product Quality Choice (chain Drug Marketing Association). The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
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 at 1-800-222-1222.
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
Other Information
• store at room temperature
Inactive Ingredients
citric acid, crospovidone, dextrose. FD&C RED # 40, flavor, magnesium stearate, maltodextrin, potassium citrate, silica, sodium polystyrene sulfonate, starch, sucralose.
Questions Or Comments?
1-866-467-2748
Principal Display Panel
*Compare to the Active Ingredient in Unisom® SleepMelts™
Nighttime Sleep Aid
Diphenhydramine HCI Tablets, 25 mg
24 Quick-Dissolving Tablets
Non-Habit Forming
Cherry Flavor
100% SATISFACTION GUARANTEED
Distributed By C.D.M.A., Inc.©
43157 W 9 Mile Rd
Novi, MI 48375
Questions: 248-449-9300
DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TEMPERING.
*This product is not manufactured or distributed by Chattern Inc., owner of the registered trademark Unisom® SleepMelts™
* Please review the disclaimer below.