Active Ingredient (In Each Banded Capsule)
Diphenhydramine Hydrochloride 25 mg
Diphenhydramine Hcl
FDA Label NDC 71399-8028
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Akron Pharma Inc. for the product Diphenhydramine Hcl (NDC 71399-8028). 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 active ingredient (in each banded capsule), purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
Uses
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
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
- difficulty in urination due to enlargement of the 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
- marked drowsiness may occur
- avoid alcoholic beverages
- alcohol, sedatives, and tranquilizers may increase drowsiness
- excitability may occur, especially in children
- be careful when driving a motor vehicle or operating machinery
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 (1-800-222-1222) right away.
Directions
- take every 4 to 6 hours
- do not take more than 6 doses in 24 hours
| Age | Dose |
| adults and children 12 years and over | 1 to 2 capsules |
| children 6 to under 12 years of age | 1 capsule |
| children under 6 years of age | do not use this product in children under 6 years of age |
Other Information
- store at temperature 15° to 30° C (59° to 86°F)
- do not use if either capsule band or imprinted safety seal under cap is broken or missing
- protect from moisture
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, hard gelatin capsules, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline
cellulose, propyl paraben sodium.
Questions Or Comments?
Call toll-free 1-877-225-6999
Mfg Lic .No: TN/DRUGS/558/1997
Manufactured for:
Akron Pharma, Inc,
373 RT US 46 W, Building E,
Suite 117, Fairfield, NJ 07004
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