FDA Label for 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
- PREGNANCY/BREASTFEEDING
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- STORAGE
- INACTIVE INGREDIENTS
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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 25 mg
Purpose
Nighttime sleep-aid
Use(S)
- for the relief of occasional sleeplessness
- reduces time to fall asleep if you have difficulty falling asleep
Do Not Use
- for children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
- with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
Ask A Doctor Before Use If
- a breathing problem such as asthma, emphysema or chronic bronchitis
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
- heart disease
Ask A Doctor Or Pharmacist Before Use If
you are taking sedatives or 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
Stop Use And Ask A Doctor If
if sleeplessness persists continuously for more than 2 weeks.
- Insomnia may be a symptom of serious underlying medical illness.
Pregnancy/Breastfeeding
ask a health professional before use.
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 (1-800-222-1222) right away.
Directions
take only one dose per day (24 hours) - see Overdose warning
Adults and children 12 years and over: ONE dose = TWO 25 mg softgels (50 mg) at bed time if needed or as directed by a doctor
Other Information
Do not use if blister unit is torn or open.
Do not use if imprinted safety seal under cap is broken or missing.
Storage
- store at 15-30° C (59-86° 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, purified water, sorbitol special, white edible ink
Questions
Call 1-888-952-0050 Monday through Friday 9AM - 5PM EST
Principal Display Panel
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