FDA Label for Diphenhydramine Hydrochloride
View Indications, Usage & Precautions
- ACTIVE INGREDIENT
- PURPOSE
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING
- KEEP OUT OF THE REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- DIPHENHYDRAMINE HCL 50 MG RR GELCAPS
Diphenhydramine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Pharmacy Value Alliance, 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
(in each gelcap)
Diphenhydramine HCl USP 50 mg
Purpose
Nighttime sleep-aid
Uses
■ for relief of occasional sleeplessness
Do Not Use
■ for 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
■ a breathing problem such as emphysema, or chronic bronchitis
■ glaucoma
■ difficulty in urination due to enlargement of the prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers
When Using This Product
■ avoid alcoholic beverages
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 The Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
adults & children 12 years of age and over: 1 gelcap (50 mg) at bedtime if needed, or as directed by a doctor
Other Information
■ store at 20°-25°C (68°-77°F). See USP Controlled Temperature.
■ avoid high humidity
Inactive Ingredients
ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, D&C red #33, dicalcium phosphate dihydrate, FD&C blue #1, FD&C yellow #6, gelatin, hydroxy propyl cellulose, hypromellose, isopropyl alcohol, lecithin, magnesium stearate, microcrystalline cellulose, n-butyl alcohol, polyethylene glycol, polyvinyl alcohol, propylene glycol, shellac, talc, titanium dioxide, xanthan gum.
Questions Or Comments?
call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST
Diphenhydramine Hcl 50 Mg Rr Gelcaps
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