Allergy Relief Dye-free Softgel Capsule, Liquid Filled
FDA Label NDC 51316-998
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy, Inc for the product Allergy Relief Dye-free Softgel (NDC 51316-998). 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 ingredients (in each softgel), 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 Ingredients (In Each Softgel)
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
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 • difficulty in urination due to enlargement to the 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. 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 6 under years | do not use |
Other Information
• store at 25°C (77°F) in a dry place
• protect from light, heat and moisture
Inactive Ingredients
gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, purified water, sorbitol sorbitan solution, white ink
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