FDA Label for Nighttime Sleep Aid
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH SOFTGEL)
- PURPOSE
- USE
- WARNINGS
- DO NOT USE THIS PRODUCT
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE NOW TAKING
- 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
- PRODUCT LABEL
Nighttime Sleep Aid Product Label
The following document was submitted to the FDA by the labeler of this product Best Choice (valu Merchandisers Company). 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.
Active Ingredient (In Each Softgel)
Diphenhydramine HCl 50 mg
Purpose
Nighttime sleep- aid
Use
- helps to reduce difficulty falling asleep
Warnings
Do not give to children under 12 years of age.
Do Not Use This Product
- With other products containing diphenhydramine, even one used on skin.
Ask A Doctor Before Use If You Have
- emphysema
- chronic bronchitis
- glaucoma
- difficulty in urination due to an enlargement of the prostate gland
Ask Doctor Or Pharmacist Before Use If You Are Now Taking
Sedatives or tranquilizers
When Using This Product
avoid alcoholic beverages
Stop Use And Ask A Doctor If
- sleeplessness persists for more than 2 weeks. Insomnia may be a symptom of a 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: take 1 softgel at bedtime if needed or as directed by a doctor
Other Information
- Store at controlled room temperature 15°-30°C (59°-86°F)
*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Maximum Strength Unisom SleepGels®
Inactive Ingredients
Edible white ink, FD&C Blue #1, gelatin, glycerin, polyethylene glycol, purified water and sorbitol special.
Questions Or Comments ?
call toll free 1-877-753-3935
Principal Display Panel
*Compare to the Active Ingredient in Maximum Strength Unisom SleepGels®
Nighttime Sleep Aid
Diphenhydramine HCl 50 mg
Helps to reduce difficulty falling asleep
THIS PRODUCT IS SEALED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
Product Label
Diphenhydramine HCl 50 mg
* Please review the disclaimer below.
