FDA Label for Severe Congestion And Cough Relief
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH 20 ML)
- PURPOSE
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Severe Congestion And Cough Relief Product Label
The following document was submitted to the FDA by the labeler of this product L.n.k. International, 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.
Active Ingredients (In Each 20 Ml)
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCl 10 mg
Purpose
Cough suppressant
Expectorant
Nasal decongestant
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help you get to sleep
- nasal congestion due to a cold
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
Do Not Use
- for children under 12 years of age
- 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
- diabetes
- high blood pressure
- thyroid disease
- difficulty in urination due to enlargement of the prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
- cough that occurs with too much phlegm (mucus)
When Using This Product
do not exceed recommended dosage.
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- symptoms do not get better within 7 days or occur with fever
- cough comes back or occurs with rash or headache that lasts.
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
- do not take more than 6 doses in any 24-hour period
- mL = milliliter; FL OZ = fluid ounce
- use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
- adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
- children under 12 years: do not use
Other Information
- each 20 mL contains: sodium 10 mg
- TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
- use by expiration date on package
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients
anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose, xanthan gum
Questions Or Comments?
1-800-426-9391
Principal Display Panel
SOUNDBODY™
Compare to the active ingredients in Mucinex® FAST-MAX™ Severe Congestion & Cough
NDC 50844-400-45
MAXIMUM STRENGTH
Severe
Congestion and
Cough Relief
Dextromethorphan HBr
Guaifenesin
Phenylephrine HCl
Cough Suppressant
Expectorant
Nasal Decongestant
Controls Cough
Relieves Nasal & Chest Congestion
Thins & Loosens Mucus
6 FL OZ (177 mL)
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by Reckitt Benckiser LLC, owner of the registered trademark Mucinex® FAST-MAX™ Severe Congestion & Cough.
50844 ORG121600445
Manufactured for Big Lots Stores, Inc.
by LNK INTERNATIONAL, INC
60 Arkay Drive, Hauppauge,
NY 11788 USA
V#733000 ITEM#022700445
* Please review the disclaimer below.