MediGummies

Manufacturer
Harmony Foods D/B/A Santa Cruz Pharmaceuticals | Confab Laboratories Inc. | Neopharm Labs Inc
Effective date
2019-07-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:17:47

Label at a glance#

ProductMediGummies Allergy and Sinus
Active ingredientCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure13 sections

Indications and uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes nasal congestion itching of the nose or throat

Dosage and administration

do not take more than 6 doses in 24 hours adults and children 12 year of age and over take 1 gel every 4 hours children 6 years of age to under 12 years of age take ½ gel every 4 hours children under 6 years of age ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each chewable gel)

OTC - ACTIVE INGREDIENT SECTION

Chlorpheniramine maleate 4 mg

Phenylephrine HCl 10 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • nasal congestion
  • itching of the nose or throat

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • heart disease
  • high blood pressure
  • thyroid disease
  • glaucoma
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed
  • drowsiness may occur
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • alcohol, sedatives, and tranquilizers may increase drowsiness effect
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not get better in 7 days or are accompanied by a fever

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than 6 doses in 24 hours
adults and children 12 year of age and over take 1 gel every 4 hours
children 6 years of age to under 12 years of age take ½ gel every 4 hours
children under 6 years of age ask a doctor

Other information

OTHER SAFETY INFORMATION

Keep carton for full drug facts.

Store at room temperature 20°-25°C (68°-77°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cherry Flavor (artificial), Citric Acid, Collagen Protein, Color (Red FD&C #40), Glycerin, Granular Sugar, Hydrogenated Starch Hydrolysate, Lubricant (containing one or more of the following: Palm Oil, Coconut Oil, Carnauba Wax, Beeswax), Pectin, Purified Water, Sodium Citrate, Sucralose.

Questions or comments?

OTC - QUESTIONS SECTION

call 1-800-XXX-XXXX

Principal Display Panel - Allergy and Sinus 15 Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 42271-200-15

MediGummies™

BIG RELIEF, CHEWY LITTLE BITE

ALLERGY
& SINUS

Chlorpheniramine 4mg,
Phenylephrine 10mg

• Sniffling • Sinus Pressure

• Sneezing • Itchy, Watery Eyes

Child Resistant

Individually
Sealed

Portable

15
CHEWABLE
GELS

Principal Display Panel - Allergy and Sinus 15 Carton Label
Principal Display Panel - Allergy and Sinus 15 Carton Label

Principal Display Panel - Allergy and Sinus 30 Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 42271-200-30

MediGummies™

BIG RELIEF, CHEWY LITTLE BITE

ALLERGY
& SINUS

Chlorpheniramine 4mg,
Phenylephrine 10mg

• Sniffling • Sinus Pressure

• Sneezing • Itchy, Watery Eyes

Child Resistant

Individually
Sealed

Portable

30
CHEWABLE
GELS

Principal Display Panel - Allergy and Sinus 30 Carton Label
Principal Display Panel - Allergy and Sinus 30 Carton Label

Principal Display Panel - Allergy and Sinus 45 Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 42271-200-45

MediGummies™

BIG RELIEF, CHEWY LITTLE BITE

ALLERGY
& SINUS

Chlorpheniramine 4mg,
Phenylephrine 10mg

• Sniffling • Sinus Pressure

• Sneezing • Itchy, Watery Eyes

Child Resistant

Individually
Sealed

Portable

45
CHEWABLE
GELS

Principal Display Panel - Allergy and Sinus 45 Carton Label
Principal Display Panel - Allergy and Sinus 45 Carton Label

Principal Display Panel - Allergy and Sinus 60 Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 42271-200-60

MediGummies™

BIG RELIEF, CHEWY LITTLE BITE

ALLERGY
& SINUS

Chlorpheniramine 4mg,
Phenylephrine 10mg

• Sniffling • Sinus Pressure

• Sneezing • Itchy, Watery Eyes

Child Resistant

Individually
Sealed

Portable

60
CHEWABLE
GELS

Principal Display Panel - Allergy and Sinus 60 Carton Label
Principal Display Panel - Allergy and Sinus 60 Carton Label

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42271-20042271-200-15, 42271-200-30, 42271-200-45, 42271-200-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

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
8eed2d4d-f40d-02bb-e053-2a95a90a880f9f33e21e-c753-46f2-aff5-bd885af697d72019-07-30WarningsExact identifier
spl id: 8eed2d4d-f40d-02bb-e053-2a95a90a880f
spl set id: 9f33e21e-c753-46f2-aff5-bd885af697d7

Reported adverse events (FAERS/openFDA)#

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