FDA Label for Diphenhydramine Hydrochloride
View Indications, Usage & Precautions
Diphenhydramine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Advance Pharmaceutical Inc.. 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 capsule)
Diphenhydramine HCl 50 mg
Purpose
Antihistamine
Uses
temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
- runny nose
- itchy nose or throat
- sneezing
- itchy, watery eyes
Warnings
Do not use 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.
Directions
- adults and children 12 years and over: take 1 capsule every 4-6 hours; not more than 6 doses in 24 hours
- children under 12 years: ask a doctor
Other Information
- store at 15-30 °C (59-86 °F)
- protect from moisture
- For 1000 Count: THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN
Inactive Ingredients
benzyl alcohol, butylparaben, D&C red# 28, edible black ink, FD&C bule #1, FD&C red# 40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium laurel sulfate
Questions Or Comments
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED
Manufactured by: Advance Pharmaceutical Inc. Holtsville, NY 11742
Package Label.Principal Display Panel
DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, USP 50 MG
ANTIHISTAMINE
NDC: 17714-021-01 – 100 COUNT
NDC: 17714-021-10 – 1000 COUNT (THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN)
* Please review the disclaimer below.