FDA Label for Sleep-aid Diphenhydramine Hcl
View Indications, Usage & Precautions
Sleep-aid Diphenhydramine Hcl Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health 110, Llc. Dba Leader. 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 Softgel)
Diphenhydramine HCl 25 mg
Purpose
Nighttime sleep-aid
Uses
•for relief of occasional sleeplessness
•reduces time to fall asleep if you have difficulty falling asleep
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 such as antihistamines and nighttime cold/flu products
Ask a doctor before use if you have •glaucoma •heart diseases •a breathing problem such as emphysema, asthma, or chronic bronchitis
•difficulty in urination due to enlargement of the prostate gland
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. Be careful when driving a motor vehicle or operating machinery.
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 breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
Directions
•take only one dose per day (24 hours)
| adults and children 12 years and 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) •protect from light
Inactive Ingredients
edible white ink, FD&C blue#1, FD&C red#40, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, purified water, sorbitol sorbitan solution
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Packaging
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