FDA Label for Nighttime Sleep Aid
View Indications, Usage & Precautions
- ACTIVE INGREDIENT(S)
- PURPOSE
- USE(S)
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREASTFEEDING,
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS/COMMENTS
- PRINCIPAL DISPLAY PANEL
Nighttime 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 50 mg (in each 30 mL)
Purpose
Nighttime sleep-aid
Use(S)
- for the relief of occasional sleeplessness
- reduces time to fall asleep if you have difficulty falling asleep
Do Not Use
- for children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
- with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu product
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
Ask A Doctor Or Pharmacist Before Use If
if you are taking sedatives or tranquilizers
When Using This Product
avoid alcoholic beverages.
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.
If Pregnant Or 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
• take only one dose (30 mL) per day (24 hours)
• only use dose cup provided
| Age | Dose |
| adults & children 12 yrs & over | 30 mL at bedtime if needed or as directed by a doctor |
| children under 12 yrs | do not use |
Other Information
• each 30 mL dose cup contains: sodium 24 mg
• store between 15-30°C (59-86°F).
TAMPER EVIDENT: DO NOT USE IF PRINTED NECK WRAP IS BROKEN OR MISSING
Inactive Ingredients
anhydrous citric acid, FD&C Blue #1, FD&C
Red #40, flavor, glycerin, menthol, propylene glycol, purified water,
sodium benzoate, sodium citrate, sorbitol, sucralose.
Questions/Comments
Call 1-888-952-0050
(Monday-Friday 9 AM – 5 PM EST)
Principal Display Panel
Nighttime Sleep Aid
* Please review the disclaimer below.
