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

Drug Labeling and Warnings

Drug Details [pdf]

MEDIGUMMIES COLD 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, ALLERGY & SINUS, Chlorpheniramine 4mg, 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 common cold symptoms:

• runny nose
• sneezing
• nasal congestion
• sinus congestion and pressure

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 - Cold and Sinus 15 Carton Label

NDC: 42271-100-15

MediGummies™

BIG RELIEF, CHEWY LITTLE BITE

COLD &
SINUS

Chlorpheniramine 4 mg,
Phenylephrine 10mg

Sniffling Sinus Pressure

Sneezing Stuffy Nose

Child Resistant

Individually
Sealed

Portable

15
CHEWABLE
GELS

Principal Display Panel - Cold and Sinus 30 Carton Label

NDC: 42271-100-30

MediGummies™

BIG RELIEF, CHEWY LITTLE BITE

COLD &
SINUS

Chlorpheniramine 4 mg,
Phenylephrine 10mg

Sniffling Sinus Pressure

Sneezing Stuffy Nose

Child Resistant

Individually
Sealed

Portable

30
CHEWABLE
GELS

Principal Display Panel - Cold and Sinus 45 Carton Label

NDC: 42271-100-45

MediGummies™

BIG RELIEF, CHEWY LITTLE BITE

COLD &
SINUS

Chlorpheniramine 4 mg,
Phenylephrine 10mg

Sniffling Sinus Pressure

Sneezing Stuffy Nose

Child Resistant

Individually
Sealed

Portable

45
CHEWABLE
GELS

Principal Display Panel - Cold and Sinus 60 Carton Label

NDC: 42271-100-60

MediGummies™

BIG RELIEF, CHEWY LITTLE BITE

COLD &
SINUS

Chlorpheniramine 4 mg,
Phenylephrine 10mg

Sniffling Sinus Pressure

Sneezing Stuffy Nose

Child Resistant

Individually
Sealed

Portable

60
CHEWABLE
GELS

MEDIGUMMIES  COLD AND SINUS
chlorpheniramine maleate and phenylephrine hydrochloride chewable gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42271-100
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	red (red)	Score	no score
Shape	SEMI-CIRCLE (SEMI-CIRCLE)	Size	20mm
Flavor	CHERRY (CHERRY)	Imprint Code	Part341
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42271-100-15	1 in 1 CARTON	12/31/2017	08/05/2019
1		15 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 42271-100-30	2 in 1 CARTON	12/31/2017	08/05/2019
2		15 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 42271-100-45	3 in 1 CARTON	12/31/2017	08/05/2019
3		15 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 42271-100-60	4 in 1 CARTON	12/31/2017	08/05/2019
4		15 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/31/2017	08/05/2019

Labeler - Harmony Foods D/B/A Santa Cruz Pharmaceuticals (093223865)

Establishment
Name	Address	ID/FEI	Business Operations
Confab Laboratories Inc.		241754217	manufacture(42271-100) , label(42271-100) , pack(42271-100)

Establishment
Name	Address	ID/FEI	Business Operations
Neopharm Labs Inc		243379372	analysis(42271-100)

Revised: 8/2019

Document Id: 8f659342-7084-6638-e053-2995a90a3e39

34390-5

Set id: dcf55772-951c-4c26-9d40-7d8cb85bcab6

Version: 3

Effective Time: 20190805

 

Harmon