FDA Label for Nighttime Sleep Aid
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH SOFTGEL)
- PURPOSE
- USE
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- DIRECTIONS
- OTHER INFORMATION
- 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 Puracap Pharmaceutical 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
Use
- for the relief of occasional sleeplessness
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 enlarged prostate gland
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
Otc - When Using
When using this product avoid alcoholic drinks
Otc - Stop Use
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.
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.
Overdosage
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 12 years of age and over:
1 softgel (50mg) at bedtime if needed, or as directed by a doctor
Other Information
- store at room temperature 15°-30° C (59°-86° F)
Inactive Ingredients
FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution and white edible ink
Questions Or Comments?
Call toll free: 1-855-215-8180
Principal Display Panel
Nighttime SLEEP-AID 100 Softgels
Diphenhydramine HCl 50mg
compare to active ingredient in Unisom ® SleepGels ® SoftGels
NDC 51013-817-01
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