FDA Label for Sleep Aid
View Indications, Usage & Precautions
Sleep Aid Product Label
The following document was submitted to the FDA by the labeler of this product Pioneer Life Sciences, 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.
Active Ingredient
Diphenhydramine Hcl 25mg
Purpose
Sleep-aid
Uses:
for relief of occasional sleeplessness
Warnings:
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
Ask Doctor:
Ask a doctor before use if you have -
a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland
Ask Doctor/Pharmacist:
Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers.
When Using This Product
drowsiness will occur
avoid alcoholic drinks
do not drive a motor vehicle or operating machinery
Pregnancy
If pregnant or breast-feeding, 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
do not take more than directed (see overdose warning)
adults and children 12 years of age and over: - take 2 caplets at bedtime if needed, or as directed by a doctor
children under 12 years of age: do not use
Other Information
each caplet contains: calcium 15 mg
store between 20°-25°C (68°-77°F); avoid high humidity
protect from light
read all product information before using
Inactive Ingredients
dicalcium phosphate, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, opadry II
Questions Or Comments?
Call 1-732-698-5070 Monday through Friday 9AM–5PM EST or www.pioneerlifesciences.com
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.
* Please review the disclaimer below.