FDA Label for Zzzsleep
View Indications, Usage & Precautions
Zzzsleep Product Label
The following document was submitted to the FDA by the labeler of this product Velocity Pharma. 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 tablet)
Diphenhydramine HCl 25mg
Purpose
Sleep Aid
Uses
- For the relief of occasional sleeplessness
- Reduces time to fall asleep if have difficulty falling asleep
Warnings
Do not use
- If children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
- with other drug that cause drowsiness such as antihistamines and nighttime cold/flu products
- Do not use with generic NyQuil®
- A breathing problem such as asthma, emphysema, or Chronic bronchitis
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
- heart disease
- You are taking a diuretic
Ask a doctor or pharmacist before use if you are taking sedative or tranquilizers or any other sleep-aid, when using this product :
- Avoid alcoholic beverages and other drugs that cause drowsiness
- Drowsiness will occur
- Be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks.
Insomnia may be a symptom of serious underlying medical illness.
If pregnant or breast-feeding, ask a health professional before use.
Ask a doctor before use if you have:
Keep Out Of Reach Of Children.
Overdose Warning: Taking more than directed can cause serious health problems, In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
Take only one dose per day (24 hours)- see Overdose warning.
Adults and Children 12 years and over
- One Dose = Two 25 mg LiquiCaps (50 mg) at bedtime if needed or as directed by a doctor
Other Information
- Store at 20-25°C (68-77°F)
- Avoid excessive heat above 40°C(104°F) and high humidity
- Protect from light
Inactive Ingredients
FD&C Blue No. 1, FD&C Red No. 40, Gelatin, Glycerin, Polyethylene Glycol, Purified Water, Sorbitol, Titanium Dioxide
Questions?
Call 1-855-314-1850
TAMPER EVIDENT: This Package is safety sealed & child resistant. Use only if blisters are intact. If difficult to open, use scissors.
Package Label.Principal Display Panel
NDC: 76168-066-02 –12 LIQUID GELS
Not for treating cold or flu – see warnings
* Please review the disclaimer below.