MEDIGUMMIES ALLERGY AND SINUS- chlorpheniramine maleate and phenylephrine hydrochloride chewable gel 
Harmony Foods D/B/A Santa Cruz Pharmaceuticals

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.

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MediGummies, COLD & SINUS, Chlorpheniramine 4 mg, Phenylephrine 10mg

Drug Facts

Active ingredients (in each chewable gel)

Chlorpheniramine maleate 4 mg

Phenylephrine HCl 10 mg

Purpose

Antihistamine

Nasal decongestant

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

Warnings

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

  • 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

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

When using this product

  • 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

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

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

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

Directions

  • 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

Keep carton for full drug facts.

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

Inactive ingredients

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?

call 1-800-XXX-XXXX

Principal Display Panel - Allergy and Sinus 15 Carton Label

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 30 Carton Label

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 45 Carton Label

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 60 Carton Label

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
MEDIGUMMIES  ALLERGY AND SINUS
chlorpheniramine maleate and phenylephrine hydrochloride chewable gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42271-200
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
CHERRY (UNII: BUC5I9595W)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
PORK COLLAGEN (UNII: I8442U2G7J)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
SUCROSE (UNII: C151H8M554)  
HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)  
PALM OIL (UNII: 5QUO05548Z)  
COCONUT OIL (UNII: Q9L0O73W7L)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
PECTIN (UNII: 89NA02M4RX)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Colorred (red) Scoreno score
ShapeSEMI-CIRCLE (SEMI-CIRCLE) Size20mm
FlavorCHERRY (CHERRY) Imprint Code part341
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42271-200-151 in 1 CARTON12/31/201707/31/2019
115 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:42271-200-302 in 1 CARTON12/31/201707/31/2019
215 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:42271-200-453 in 1 CARTON12/31/201707/31/2019
315 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:42271-200-604 in 1 CARTON12/31/201707/31/2019
415 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/31/201707/31/2019
Labeler - Harmony Foods D/B/A Santa Cruz Pharmaceuticals (093223865)
Establishment
NameAddressID/FEIBusiness Operations
Confab Laboratories Inc.241754217manufacture(42271-200) , label(42271-200) , pack(42271-200)
Establishment
NameAddressID/FEIBusiness Operations
Neopharm Labs Inc243379372analysis(42271-200)

Revised: 7/2019
Document Id: 8eed2d4d-f40d-02bb-e053-2a95a90a880f
Set id: 9f33e21e-c753-46f2-aff5-bd885af697d7
Version: 3
Effective Time: 20190730
 
Harmony Foods D/B/A Santa Cruz Pharmaceuticals