FDA Label for Allergy
View Indications, Usage & Precautions
Allergy Product Label
The following document was submitted to the FDA by the labeler of this product Velocity Pharma. 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 tablet)
Diphenhydramine HCl 25 mg
Purpose
Antihistamine
Uses
temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
- runny nose
- itching of the nose or throat
- sneezing
- itchy, watery eyes
temporarily relieves these symptoms due to the common cold:
- runny nose
- sneezing
Warnings
Do not use
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
When using this product
- you may get very drowsy
- avoid alcoholic drinks
- alcohol, sedatives & tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
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. (1-800-222-1222)
Directions
- adults and children 12 years and over : take 1-2 tablets every 4 to 6 hours; not more than 6 doses in 24 hours
- children under 12 years: ask a doctor
Other Information
- save carton for full directions and warnings
- store at 25°C(77 °F) excusrsions permitted between 15°-30°C (59°-86°F)
- this product contains 100.75 milligrams of calcium.
- Do not use if imprinted safety seal under cap is broken or missing
Inactive Ingredients
Carnauba Wax, Colloidal silion dioxide, croscarmellose sodium, D&C red #27 al lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80,Titanium Dioxide
Questions Or Comments
Call 1-855-314-1850
READ AND KEEP CARTON FOR COMPLETE WARNING AND INFORMATION
Package Label.Principal Display Panel
DIPHENHYDRAMINE HYDROCHLORIDE TABLET, USP 25 MG
ANTIHISTAMINE
NDC:76168-013-07 36TABLETS
NDC:76168-013-12 100 TABLETS
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