Goodmeds Allergy Relief Tablet
FDA Label NDC 82725-4201
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cabinet Health P.b.c. for the product Goodmeds Allergy Relief (NDC 82725-4201). 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 (in each tablet), 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Tablet)
Diphenhydramine HCl 25 mg
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 •temporarily relieves these symptoms due to the common cold: •runny nose •sneezing
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
• 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
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
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. (1-800-222-1222)
Directions
• take every 4 to 6 hours or as directed by a doctor
• do not take more than 6 doses in 24 hours
| adults and children 12 years and over | 1 to 2 tablets |
| children 6 to under 12 years | 1 tablet |
| children under 6 years | do not use |
Other Information
- do not use if imprinted safety seal under cap is broken or missing
- each tablet containscalcium 24 mg
- store between 20–25°C (68–77°F).
- protect from moisture and light
Inactive Ingredients
croscarmellose sodium, d&c red no 27 aluminum lake, dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, polysorbate 80, talc, titanium dioxide
Questions Or Comments?
contact 1-908-242-6108Mon-Fri 8:00 AM to 5:00 PM EST
Package Labeling:
Label2 (Label2)
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