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
- 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 50mg
Purpose
Nighttime sleep-aid
Use(S)
- reduces time to fall asleep if you have difficulty falling asleep
- for relief of occasional sleeplessness
Do Not Use
- Do not use n for children under 12 years of age.
- with any other product containing diphenhydramine, even one used on skin
- with any other drugs that cause drowsiness such as antihistamines and nighttime cough, cold/flu products
Ask A Doctor Before Use If
- heart disease
- trouble urinating due to an enlarged prostate gland
- glaucoma
- a breathing problem such as asthma, emphysema or chronic bronchitis
Ask A Doctor Or Pharmacist Before Use If
you are taking sedatives or tranquilizers or any other sleep aid
When Using This Product
- do not use more than directed
- avoid alcoholic beverages and other drugs that cause drowsiness
- drowsiness will occur
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives, and tranquilizers may increase drowsiness
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 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 right away.
Directions
- take only as recommended
- use dosage cup or tablespoon
Age Dose
Adults & children
12 years & over: One Dose = 2 tablespoons (30 mL) at bed time if needed or as directed by a doctor
Children under 12 yrs: Do not use
Other Information
- each 30 mL dose (2 tablespoons) contains: sodium 23 mg
- dosage cup provided
- store at room temperature
Inactive Ingredients
citric acid, FD&C Blue #1, FD&C Red #40, flavor, high fructose corn syrup,
poloxamer 407, propylene glycol, purified water, sodium benzoate, sodium
citrate, sodium saccharin
Questions/Comments
Call 1-888-952-0050 Monday through Friday 9AM to 5PM
Principal Display Panel
Sleep Aid Liquid
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