Drug Facts
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Diphenhydramine Hydrochloride
FDA Label NDC 67296-1055
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Redpharm Drug, Inc. for the product Diphenhydramine Hydrochloride (NDC 67296-1055). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, indications & usage, warnings, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
(in each capsule)
Diphenhydramine HCl 25 mg
Purpose
Antihistamine
Indications & Usage
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 to 2 capsules 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 is a bulk package. Dispense contents in a tight, light-resistant container with a child-resistant closure as defined in the USP
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
Distributed by: Qualitest Pharmaceuticals, Inc.
Dosage & Administration
adults and children 12 years and over: take 1 to 2 capsules every 4-6 hours; not more than 6 doses in 24 hours
children under 12 years: ask a doctor
Package Label.Principal Display Panel
Diph (Doc20180425135416 001)
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