Active Ingredient (In Each Piece)
Diphenhydramine HCl 25 mg
Adult Allergy Relief Bar, Chewable
FDA Label NDC 73282-2520
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Calmco for the product Adult Allergy Relief (NDC 73282-2520). 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 piece), purpose, uses, do not use, when using this product, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, 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
■ itchy, watery eyes
■ sneezing
■ itching of the nose or throat
• temporarily relieves these symptoms due to the common cold:
■ runny nose
■ sneezing
Do Not Use
• To make child sleepy
• with any other product containing diphenhydramine, even one used on skin
When Using This Product
• marked drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children
Ask A Doctor Before Use If You Have
• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• trouble urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers
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, or as directed by a doctor
• do not take more than 6 times in 24 hours
• chew each piece thoroughly before swallowing
Dosage Chart
| Age (yr) | Dose (piece) |
| Adults and children 12 years and older | 1 to 2 pieces (25 to 50 mg) |
| Children under 12 years | Do not use |
Other Information
• each piece: contains
sodium 9 mg.
low sodium
• store in a cool dry place between 20-25°C (68-77°F).
•
Child Resistant Container; do not use if printed seal under cap is broken or missing.
Inactive Ingredients
Inactive ingredients: FD&C Red# 40, flavors, geleol mono and diglycerides, glucose syrup, gum atabic,
hydroxypropyl betadex, maltitol solution, neotame, polyethylene glycol 400, povidone K30, propylene
glycol, purified water, seaweed extract ( carrageenan), sodium chloride, starch, sucralose, sucrose,
trisodium citrate dihydrate.
Questions Or Comments
Call 941-203-4590 or visit calmco.com
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