FDA Label for Nighttime Sleep Aid
View Indications, Usage & Precautions
- DRUG FACTS
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- OTHER
- 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.
Drug Facts
Active Ingredient (In Each Tablet)
Diphenhydramine Hydrochloride 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
Otc - Do Not Use
Do not use • for children under 12 years of age • with any other product containing diphenhydramine, even one used on skin.
Otc - Ask Doctor
Ask a doctor before use if you have
• a breathing problem such as emphysema or chronic bronchitis • glaucoma
• difficulty in urination due to enlargement of the 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 beverages
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. 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)
| adults & children 12 years & over | take 2 softgels at bedtime 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, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide
Questions Or Comments?
1-888-333-9792
Other
Distributed By:
Spirit Pharmaceuticals, LLC
Ronkonkoma, NY 11779
Made in India
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