FDA Label for Nighttime 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
- IF PREGNANT OR BREASTFEEDING,
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS/COMMENTS
- PRINCIPAL DISPLAY PANEL
Nighttime Sleep Aid Product Label
The following document was submitted to the FDA by the labeler of this product Family Dollar Stores, Inc. 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)
Doxylamine succinate 25 mg
Purpose
Nighttime sleep-aid
Use(S)
helps to reduce difficulty in falling asleep
Do Not Use
- in children under 12 years of age
Ask A Doctor Before Use If
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- difficulty in urination due to an enlargement of the prostate gland
Ask A Doctor Or Pharmacist Before Use If
you are taking any other drugs.
When Using This Product
- avoid alcoholic beverages
- take only at bedtime
Stop Use And Ask A Doctor If
sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of
a serious underlying medical illness.
If Pregnant Or Breastfeeding,
ask a health professional before use.
Keep Out Of Reach Of Children
Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
Adults and children 12 years and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a
doctor
Children under 12 years of age: do not use
Other Information
- Do not use if blister unit is broken or torn
- store at controlled room temperature 20°– 25°C (68°– 77°F)
- use by expiration date on package
Inactive Ingredients
dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate,
microcrystalline cellulose, sodium starch glycolate
Questions/Comments
Call 1-888-952-0050 Monday through Friday 9AM - 5PM
Principal Display Panel
Sleep Aid
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