FDA Label for Nighttime Sleep Aid
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENTS (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
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL - 48 COUNT BLISTER CARTON
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
Distributed By:
Spirit Pharmaceuticals, LLC
Ronkonkoma, NY 11779
Active Ingredients (In Each Softgel)
Diphenhydramine HCl 25 mg
Purpose
nighttime sleep-aid
Uses
- for the 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 asthma, emphysema, or chronic bronchitis
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
- heart disease
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives, 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
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. 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. 1(800)222-1222
Directions
- take only one dose per day (24 hours) - see Overdose warning
adults & children 12 yrs & over | One dose=TWO 25 mg softgels (50 mg) at bed time if needed or as directed by a doctor |
children under 12 years | Do not use |
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#1, FD&C Red#40, gelatin, glycerin, polyethylene glycol-400, propylene glycol, sorbitol sorbitan, titanium dioxide
Questions Or Comments?
1-888-333-9792
Principal Display Panel - 48 Count Blister Carton
VALUMEDS™
Compare to the active ingredient
in ZzzQuil®*
NIGHTTIME
SLEEP-AID
DIPHENHYDRAMINE HCl 25 mg
Non Habit-Forming
Not for Treating Cold or Flu
See Warnings
48 SOFTGELS
* Please review the disclaimer below.