Otc - Active Ingredient Section
(in each capsule)
Diphenhydramine HCl 25 mg
Diphenhydramine Hydrochloride
FDA Label NDC 61919-078
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Direct Rx for the product Diphenhydramine Hydrochloride (NDC 61919-078). 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 otc - active ingredient section, otc - purpose section, instructions for use section, warnings section, otc - keep out of reach of children section, dosage & administration section, other safety information, inactive ingredient section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose Section
Antihistamine
Instructions For Use Section
temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
runny nose
itchy nose or throat
sneezing
itchy, watery eyes
Warnings Section
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.
Otc - Keep Out Of Reach Of Children Section
In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration Section
- 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 Safety 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 Ingredient Section
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
Otc - Questions Section
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.
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