Active Ingredient (In Each Softgel)
Diphenhydramine HCl 25 mg
Good Remedies Allergy Relief Softgel Capsule, Liquid Filled
FDA Label NDC 70692-078
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strive Pharmaceuticals Inc. for the product Good Remedies Allergy Relief Softgel (NDC 70692-078). 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 softgel), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, 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
Warnings
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 beverages
• alcohol, sedatives, and tranquilizers may increase drowsiness
• use caution 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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
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 older | 1 to 2 softgels |
| children 6 to under 12 years | 1 softgel |
| children under 6 years | do not use |
Other Information
• store at room temperature between 20°-25°C (68°-77°F)
• protect from light, heat and moisture
Inactive Ingredients
edible white ink, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, purified water, sorbitol sorbitan solution
Questions Or Comments?
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Packaging
Grdfar Softgel (70692 078)
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