KIDS-EEZE- guaifenesin tablet, orally disintegrating

Kids-EEZE by

Drug Labeling and Warnings

Kids-EEZE by is a Otc medication manufactured, distributed, or labeled by ProPhase Labs, Inc., Pharmaloz Manufacturing, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each soft chew)

Guaifenesin, USP 100 mg

Purpose

Expectorant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Warnings

Ask a doctor before use if you have

• a sodium-restricted diet
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• cough that occurs with too much phlegm (mucus)

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.

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

Chew and swallow as directed below

• Do not take more than 6 doses in 24 hours

• adults and children 12 years and over: 2 to 4 chews every 4 hours
• children 6 years to under 12 years: 1 to 2 chews every 4 hours
• children under 6 years of age: ask a doctor

Other information

• each soft chew contains 17 mg sodium
• tamper evident: do not use if inner blister pack is torn or open
• store at controlled room temperature 20-25°C (68-77°F)

Inactive ingredients

croscarmelose sodium, ethylcellulose, FD&C red #40 lake, ethylene glycol & vinyl alcohol graft copolymer, malic acid, methacrylic copolymer, monoammonium glycyrrhizinate, non fat dry milk, octaglycerol monooleate emulsifier, vegetable oil, polysorbate 80, salt, silicon dioxide, sodium starch glycolate, soy lecithin, strawberry flavors, sucralose, sugar, vanilla flavor

QUESTIONS

To report serious side effects associated with the use of this product call 1-800-505-COLD (2653)

PRINCIPAL DISPLAY PANEL - 100 mg Tablet Carton

NDC: 61941-1002-6

Kids-EEZE®

From The Makers Of
Cold-EEZE®

Chest
Relief

EXPECTORANT GUAIFENESIN 100 mg

• + Relieves Chest
  Congestion
• + Thins &
  Loosens
  Mucus

Soft Chew

Great Tasting
Strawberry

ARTIFICIALLY FLAVORED
12 SOFT CHEWS

TAMPER EVIDENT: Do Not Use If Inner Seal Is Torn Or Open

INGREDIENTS AND APPEARANCE

KIDS-EEZE   CHEST RELIEF
guaifenesin tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61941-1002
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	100 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ETHYLCELLULOSE (4 MPA.S) (UNII: KC5472WRJK)
ETHYLENE GLYCOL (UNII: FC72KVT52F)
MALIC ACID (UNII: 817L1N4CKP)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2) (UNII: 5KY68S2577)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	RED	Score	no score
Shape	OVAL	Size	23mm
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61941-1002-1	72 in 1 CASE
1	NDC: 61941-1002-6	12 in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	09/01/2008

Labeler - ProPhase Labs, Inc. (620557298)

Establishment
Name	Address	ID/FEI	Business Operations
ProPhase Labs, Inc.		620557298	LABEL, ANALYSIS

Establishment
Name	Address	ID/FEI	Business Operations
Pharmaloz Manufacturing, Inc.		067101998	MANUFACTURE, ANALYSIS, PACK, REPACK