FDA Label for Kids-eeze Cough And Cold
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- USES
- OTC - DO NOT USE
- OTC - ASK DOCTOR/PHARMACIST
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- OTC - QUESTIONS
- PRINCIPAL DISPLAY PANEL - 12 SOFT CHEW PACKAGE
Kids-eeze Cough And Cold Product Label
The following document was submitted to the FDA by the labeler of this product Prophase Labs, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Otc - Purpose
| Active ingredients (in each soft chew) | Purposes |
|---|---|
| Dextromethorphan Hydrobromide 5mg | Cough Suppressant |
| Phenylephrine Hydrochloride 2.5mg | Nasal Decongestant |
Uses
Temporarily
- relieves cough and nasal congestion associated with a cold or hay fever
- helps you cough less
- controls the intensity of coughing
- reduces the impulse to cough to help you sleep
- relieves the cough impulses without narcotics
- relieves stuffy nose and sinus congestion and pressure
Otc - Do Not Use
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.
Otc - Ask Doctor/Pharmacist
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
- a persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus)
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- difficulty in urination due to enlargement of the prostate gland
When Using This Product
- do not exceed recommended dosage
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash, or persistent headache. These may be symptoms of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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 | 4 chews every 4 hours |
| children 6 years to under 12 years | 2 chews every 4 hours |
| children under 6 years of age | ask a doctor |
Other Information
- each soft chew contains 6 mg sodium
- tamper evident: do not use if inner blister pack is torn or open
- store at controlled room temperature 15-30°C (59-86°F)
Inactive Ingredients
ammonium glycyrrhizinate, cellulose acetate, croscarmellose sodium, D&C red # 27 aluminum lake, eudragit E acrylic polymer, FD&C blue #1 aluminum lake, fructose, flavors, hydroxypropylmethylcellulose, lecithin, malic acid, microcrystalline cellulose, sodium chloride, sodium lauryl sulfate, sucralose, sugar, vegetable oil, xylitol
Otc - Questions
To report serious side effects associated with the use of this product call 1-800-505-COLD (2653)
Principal Display Panel - 12 Soft Chew Package
NDC 61941-1003-6
Kids-EEZE®
From The Makers Of
Cold-EEZE®
Cough
&Cold
COUGH SUPPRESSANT • DEXTROMETHORPHAN HBr 5mg
NASAL DECONGESTANT • PHENYLEPHRINE HCl 2.5mg
For relief of:
+ Coughs+ Stuffy Nose+ Sinus
Congestion
Soft Chew
Great Tasting Grape
ARTIFICIALLY FLAVORED
12 SOFT CHEWS
TAMPER EVIDENT: Do Not Use If Inner Seal Is Torn Or Open
* Please review the disclaimer below.