FDA.reportPublic FDA data

Premier Value Nausea Control

Manufacturer
PHARMACY VALUE ALLIANCE, LLC
Effective date
2024-10-28
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:31:21

Label at a glance#

ProductPremier Value Nausea Control Cherry Flavor
Active ingredientDEXTROSE, UNSPECIFIED FORM, FRUCTOSE, PHOSPHORIC ACID
Label structure10 sections

Indications and uses

▪ For relief of upset stomach associated with nausea

Dosage and administration

▪ for maximum effectiveness never dilute or drink fluids of any kind immediately before or after taking this product ▪ repeat dose every 15 minutes or until distress subsides ▪ do not take more than 5 doses in 1 hour without consulting a doctor ▪ measure only with dosing cup provided. Dosing cup to be used with this product only. Do not use with other products. ▪ mL= milliliter   age   dose   adults and children 1...

Label contents#

Full prescribing information#

Active ingredients (per 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextrose (glucose) 1.87 g

Levulose (fructose) 1.87 g

  • Phosphoric acid 21.5 mg

Purpose

OTC - PURPOSE SECTION

Upset Stomach Reliever

Uses

INDICATIONS & USAGE SECTION

  • For relief of upset stomach associated with nausea

Warnings

WARNINGS SECTION

  • This product contains fructose and should not be taken by persons with hereditary fructose intolerance (HFI).

Do not use if you have

OTC - DO NOT USE SECTION

  • allergic reactions to any of the ingredients in this product

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • diabetes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • symptoms persist, return or get worse

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • for maximum effectiveness never dilute or drink fluids of any kind immediately before or after taking this product
  • repeat dose every 15 minutes or until distress subsides
  • do not take more than 5 doses in 1 hour without consulting a doctor
  • measure only with dosing cup provided. Dosing cup to be used with this product only. Do not use with other products.
  • mL= milliliter
  1. age
  1. dose
  1. adults and children 12 years of age and over
  1. 15 mL or 30 mL
  1. children 2 to under 12 years of age
  1. 5 ml or 10 mL

Other information

SPL UNCLASSIFIED SECTION

  • Store at room temperature away from heat and direct light; keep from freezing
  • Do not use if printed seal under cap is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C red no. 40, flavors, glycerin, methylparaben, purified water.

Questions or Comments?

SPL UNCLASSIFIED SECTION

1-866-467-2748

SPL UNCLASSIFIED SECTION

NDC 68016-807-04

Premier Value®

COMPARE TO THE ACTIVE INGREDIENTS EMETROL®*

Nausea Control

Doctor Recommended

Relief from Nausea Due to Upset Stomach Safe and Effective for Children and Adults

  • No Antihistamines
  • No Salicylates
  • No alcohol
  • No Caffeine

Cherry Flavor

Naturally and Artificially Flavored

4 FL OZ (118 mL)

If any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

IMPORTANT: Keep this carton for future reference on full labeling.

DISTRIBUTED BY:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

*This product is not manufactured or distributed by Wellspring Pharmaceutical Corporation., owner of the registered trademark Emetrol®.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nausea Control Cherry FlavorNausea Control Cherry Flavor 

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
318146dextrose 1.87 GM / fructose 1.87 GM / phosphoric acid 21.5 MG in 5 mL Oral SolutionPSN6
318146fructose 374 MG/ML / glucose 374 MG/ML / phosphoric acid 4.3 MG/ML Oral SolutionSCD6
318146dextrose 1.87 GM / fructose 1.87 GM / phosphoric acid 21.5 MG per 5 ML Oral SolutionSY6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-807-04Premier Value Nausea ControlCherry Flavor1 in 1 CARTONSOLUTION16
68016-807-04Premier Value Nausea ControlCherry Flavor118 mL in 1 BOTTLESOLUTION1186

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-807PREMIER VALUE NAUSEA CONTROL CHERRY FLAVOR (DEXTROSE(GLUCOSE),LEVULOSE(FRUCTOSE),PHOSPHORIC ACID) SOLUTION [PHARMACY VALUE ALLIANCE, LLC]6Current NDC, Legacy NDC, 2 package rows20241030_8f000438-a9c3-45ca-8cb5-79151b2b3ead.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68016-80768016-807-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2ACTIB
FRUCTOSE6YSS42VSEVACTIB
PHOSPHORIC ACIDE4GA8884NNACTIB
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Premier Value Nausea Control Cherry FlavorDEXTROSE(GLUCOSE),LEVULOSE(FRUCTOSE),PHOSPHORIC ACIDPHARMACY VALUE ALLIANCE, LLC8f000438-a9c3-45ca-8cb5-79151b2b3ead2024-10-28WarningsExact identifier
ndc (package): 68016-807-04
ndc (product): 68016-807
ndc11 (package): 68016080704
spl id: eeb45790-8ef7-4d27-b114-dcd78215ff47
spl set id: 8f000438-a9c3-45ca-8cb5-79151b2b3ead

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.