DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride tablet
AAA Pharmaceutical, Inc.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Active ingredient (in each tablet)
Diphenhydramine HCl 25 mg
Purpose
Nighttime sleep-aid
Use
helps to reduce difficulty falling asleep
Warnings
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
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
When using this product avoid alcoholic drinks
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.
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
Distributed by:
AAA Pharmaceutical, Inc.
681 Main Street
Lumberton, NJ 08048
PRINCIPAL DISPLAY PANEL - 16 Tablet Blister Pack Carton
RESTORE u
NDC 57344-019-01
†COMPARE TO THE ACTIVE
INGREDIENT IN SOMINEX®
Get To Sleep Safely,
Wake Up Refreshed
Somnitabs
NIGHTTIME SLEEP-AID
Diphenhydramine HCl
16 TABLETS - 25 mg each
AAA Pharmaceutical, Inc.