FDA Label for Nighttime Sleep Aid
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT(IN EACH SOFTGEL)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- OTC - ASK DOCTOR/PHARMACIST
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Nighttime Sleep Aid Product Label
The following document was submitted to the FDA by the labeler of this product Spirit Pharmaceuticals Llc. 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.
Other
Drug Facts
Active Ingredient(In Each Softgel)
Diphenhydramine HCL 50 mg
Purpose
Nighttime sleep-aid
Uses
- for relief of occasional sleeplessness
- reduces time to fall asleep if you have difficulty falling asleep
Warnings
Warnings
Do Not Use
- for children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
Ask A Doctor Before Use If You Have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
Otc - Ask Doctor/Pharmacist
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 persist continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. 1(800)222-1222
Directions
- adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor
Inactive Ingredients
FD&C Blue#1, gelatin, glycerin, polyethylene glycol-400, propylene glycol, sorbitol, titanium dioxide, water
Questions Or Comments?
1-888-333-9792
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