Otc - Active Ingredient
Active Ingredient
(in each caplet)
Diphenhydramine Hcl 25 mg
Diphenhydramine Hydrochloride Tablet, Coated
FDA Label NDC 49483-329
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Time-cap Labs, Inc for the product Diphenhydramine Hydrochloride (NDC 49483-329). 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, otc - ask doctor, otc - ask doctor/pharmacist, otc - do not use, otc - keep out of reach of children, warnings, otc - pregnancy or breast feeding, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Ask Doctor
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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
Otc - Do Not Use
Do not use
to make a child sleepy; with any other product containing diphenhydramine, even one used on skin.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Warnings
Warnings
Do not use to make a child sleepy; Do not use with any other product containing diphenhydramine even one used on skin.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding ask a health professional before use.
Otc - Purpose
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies
runny nose; itchy water eyes sneezing;itchy nose or throat
Temporarily relieves these symptoms due to the common cold: runny nose; sneezing
Otc - When Using
When using this product
Avoid alcoholic drinks
marked drowsiness may occur
Alcohol, sedatives, and tranquilizers may increase drowsiness
Excitability may occur, especially in children
Be careful when driving a motor vehicle or operating machinery
Dosage & Administration
Directions:
Take every 4 to 6 hours
Do not take more than 6 doses in 24 hours
Adults and children 12 years of age and over - 1 to 2 caplets
Children 6 to under 12 years of age - 1 caplet
Children under 6 years of age - Do not use this product in children under 6 years of age
Inactive Ingredient
Carnauba Wax, Colloidal Silicon Dioxide, Croscarmellose Sodium, Dibasic Calcium Phosphate Dihydrate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Titanium Dioxide
Indications & Usage
Uses: Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies; runny nose, itchy watery eyes; sneezing; itchy nose or throat
Temporarily relieves these symptoms due to the common cold: runny nose; sneezing
Package Label.Principal Display Panel
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