Allergy Relief Tablet, Film Coated
FDA Label NDC 70677-1238
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services, Llc for the product Allergy Relief (NDC 70677-1238). 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) diphenhydramine hcl 25 mg, 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, warningsdo 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 • trouble urinating due to an enlarged prostate gland • glaucoma, ask a doctor or pharmacist before use if you aretaking 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, 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 • Itchy, Watery Eyes • Sneezing • Itching Of The Nose Or Throat • Temporarily Relieves These Symptoms Due To The Common Cold: • Runny Nose • Sneezing
Warningsdo 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 • Trouble Urinating Due To An Enlarged Prostate Gland • Glaucoma
Ask A Doctor Or Pharmacist Before Use If You Aretaking 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 Of Age And Over - 1 To 2 Tablets • Children 6 To Under 12 Years Of Age - 1 Tablet • Children Under 6 Years Of Age - Do Not Use
Other Information• Each Tablet Containscalcium 24 Mg • Store Between 20°-25° C (68°-77° F). • Protect From Light
Inactive Ingredients C Olloidal Silicon Dioxide, Croscarmellose Sodium, Dicalcium Phosphate, D&C Red # 27 Aluminium Lake, Lecithin, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Talc, Titanium Dioxide
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