Label: MEIJER MULTI-SYMPTOM RELIEF- polyethylene glycol, tetrahydrozoline hydrochloride, zinc sulfate solution/ drops
- NDC Code(s): 55651-250-01
- Packager: K.C. Pharmaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 6, 2023
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- DRUG FACTS
- INDICATIONS & USAGE
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WARNINGS
Warnings
For external use only
When using this product
- pupils may become enlarged temporarily
- overuse may cause more eye redness
- remove contact lenses before using
- do not touch tip of container to any surface to avoid contamination
- replace cap after using
- do not use if this solution changes color or becomes cloudy
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MEIJER MULTI-SYMPTOM RELIEF
polyethylene glycol, tetrahydrozoline hydrochloride, zinc sulfate solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55651-250 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE 0.05 g in 100 mL POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 400 1 g in 100 mL ZINC SULFATE (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37) ZINC SULFATE 0.25 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM CITRATE (UNII: 1Q73Q2JULR) BORIC ACID (UNII: R57ZHV85D4) GLYCERIN (UNII: PDC6A3C0OX) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) EDETATE DISODIUM (UNII: 7FLD91C86K) HYPROMELLOSES (UNII: 3NXW29V3WO) SODIUM CHLORIDE (UNII: 451W47IQ8X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55651-250-01 1 in 1 CARTON 01/09/2023 1 15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 01/09/2023 Labeler - K.C. Pharmaceuticals, Inc. (174450460) Establishment Name Address ID/FEI Business Operations K.C. Pharmaceuticals, Inc. 174450460 manufacture(55651-250) , pack(55651-250) , label(55651-250)