Allergy Relief
FDA Label NDC 52083-665
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kramer Novis for the product Allergy Relief (NDC 52083-665). 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 5 ml tsp), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each 5 Ml Tsp)
Diphenhydramine HCL, 12.5 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
Warnings
Do not use
• with any other product containing diphenhydramine, even one used on skin
• to make a child sleepy
Ask a doctor before use if you have
• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• trouble urinating due to the enlarged prostate gland
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
When using this product:
• excitability might occur, especially in children
• marked drowsiness may occur • avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness effect
• be careful when driving a motor vehicle or operating machinery
If pregnant or breast-feeding, ask a health professional before use.
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 (1-800-222-1222) right away.
Directions
• Take every 4 to 6 hours, or as directed by doctor.
• Do not exceed recommended dose.
| Adults and Children 12 years of age and over: | take 10 to 20 mL (2 to 4 tsp) not to exceed 300 mg in 24 hours |
| Children 6 to under 12 years of age: | take 5 to 10 mL (1 to 2 tsp) not to exceed 150 mg in 24 hours |
| Children under 6 years of age: | consult a doctor |
Other Information
• Store at controlled room temperature 15°-30°C (59°-86°F).
• Do not refrigerate. Avoid excessive heat or humidity.
• Protect from light.
Inactive Ingredients
Cherry flavor, citric acid, FD&C Red #40, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sorbitol, and sucralose
Questions Or Comments?
Call weekdays from 8 AM to 4 PM AST at 1-787-767-2072 | www.kramernovis.com
Manufactured in the USA for Kramer Novis, San Juan, PR 00917
Packaging
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