FDA Label for Sleep Aid
View Indications, Usage & Precautions
- ACTIVE INGREDIENT(S)
- PURPOSE
- USE(S)
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- PREGNANCY/BREASTFEEDING
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- STORAGE
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
Sleep Aid Product Label
The following document was submitted to the FDA by the labeler of this product Allegiant Health. 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(S)
Diphenhydramine HCl 50mg
Purpose
Nighttime sleep aid
Use(S)
for relief of occasional sleeplessness
Do Not Use
for children under 12 years of age
- with any other products containing diphenhydramine, even one used on skin
Ask A Doctor Before Use If
- 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 a serious underlying medical illness.
Pregnancy/Breastfeeding
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 (1-800-222-1222) right away.
Directions
Adults and children 12 years and over: 1 softgel (50mg) at bedtime if needed, or as directed by a doctor
Other Information
- do not use if imprinted safety seal under cap is broken or missing or
- do not use if blister unit is torn or open
Storage
store at room temperature 15° to 30°C (59° to 86°F) and avoid excessive heat
Inactive Ingredients
FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution, white ink
Principal Display Panel
* Please review the disclaimer below.