Premier Value Original
FDA Label NDC 68016-448

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Consortium, Llc for the product Premier Value Original (NDC 68016-448). 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 otc - active ingredient, otc - purpose, warnings, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient                                             Purpose

Tetrahydrozoline HCl 0.05%........................... Redness Reliever

Otc - Purpose

Use

  • for the relief of redness of the eyes due to minor eye irritations

Warnings

Warnings

Ask a doctor before use if you have narrow angle glaucoma

Otc - When Using

When using this product

  • pupils may become enlarged temporarily
  • overuse may cause more eye redness
  • remove contact lenses before using
  • do not use if this solution changes color or becomes cloudy
  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after each use

Otc - Stop Use

Stop use and ask a doctor if

  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye persists
  • condition worsens or lasts more than 72 hours

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children.

If swallowed, get medical help or contact a Poision Control Center right away.

Indications & Usage

Directions

  • To open bottle, push cap down and twist counterclockwise. To close bottle, twist clockwise until it stops turning
  • Put 1 to 2 drops in the affected eye(s) up to 4 times daily.

Storage And Handling

Other information

  • some users may experience a brief tingling sensation
  • store at 15° to 25°C (59° to 77°F)

Inactive Ingredient

Inactive ingredients:

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium chloride

Dosage & Administration

DISTRIBUTED BY:

CHAIN DRUG CONSORTIUM

3301 NW BOCA RATON BLVD

SUITE 101, BOCA RATON, FL 33431

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