FDA Label for Somnitabs
View Indications, Usage & Precautions
Somnitabs Product Label
The following document was submitted to the FDA by the labeler of this product Harris Teeter. 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.
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Drug Facts
Active Ingredient (In Each Tablet)
Diphenhydramine HCl 25 mg
Purpose
Nighttime sleep-aid
Use
helps to reduce difficulty falling asleep
Do Not Use
- in children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
Ask A Doctor Before Use If You Have
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged 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 drinks
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.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 12 years of age and over: take 2 tablets at bedtime if needed, or as directed by a doctor
Other Information
- each tablet contains: calcium 85 mg
- store at room temperature 15°-30°C (59°-86°F)
- retain carton for complete product information
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, FD&C blue #1, magnesium stearate, microcrystalline cellulose
Principal Display Panel
Harris Teeter
Somnitabs
Compare to the Active Ingredient in Sominex
Diphenhydramine HCl, 25 mg
NIGHTTIME SLEEP-AID
Fall Asleep Fast
Wake up rested and refreshed
32 Tablets
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