FDA Label for Maximum Strength Cough And Chest Congestion And Nighttime Severe Cold And Flu Combo Pack
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- OTC - ASK DOCTOR/PHARMACIST
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Maximum Strength Cough And Chest Congestion And Nighttime Severe Cold And Flu Combo Pack Product Label
The following document was submitted to the FDA by the labeler of this product Genexa 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
Daytime Cough & Chest Congestion **
Drug Facts
Nighttime Cold & Flu*
Drug Facts
DO NOT use if seal under the cap is disturbed or missing.
SHAKE WELL before each use.
*U.S. Patent No. 11,617,795 | **Patent Pending
Distributed by: Genexa Inc. Atlanta, GA 30324 | genexa.com
Made in the USA with globally sourced ingredients
NDC 69676-0079-3
Otc - Active Ingredient
Active ingredients
(in each 20 mL)
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Active ingredients (in each 20 mL)
Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine Succinate 12.5 mg
Otc - Purpose
Purposes
Cough suppressant
Expectorant
Purposes
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Indications & Usage
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
- temporarily relieves these common cold and flu symptoms:
- cough due to minor throat and bronchial irritation
- minor aches and pains
- sore throat
- headache
- runny nose
- sneezing
- temporarily reduces fever
- controls cough to help you get to sleep
Uses
Warnings
Warnings
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses in 24 hours, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- 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 MAOI, ask a doctor or pharmacist before taking this product.
Otc - Ask Doctor
Ask a doctor before use if you have
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
- liver disease
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
- glaucoma
- trouble urinating due to enlarge prostate gland
Ask a doctor before use if you have
Otc - When Using
When using this product do not use more than directed
When using this product
- do not use more than directed
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives, and tranquilizers may increase drowsiness
Otc - Stop Use
Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
Stop use and ask a doctor if
- pain or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back or occurs with rash or headache that lasts
These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
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 (1-800-222-1222).
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Dosage & Administration
- SHAKE WELL before each use
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided
- do not use dosing cup with other products
- dose as follows or as directed by a doctor
- adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours
- children under 12 years of age: do not use
- SHAKE WELL before each use
- only take as directed
- only use the dose cup provided
- do not exceed 4 doses per 24 hrs
Directions
| adults & children 12 yrs & over | 20 mL every 6 hours |
| children 4 to under 12 yrs | ask a doctor |
| children under 4 yrs | do not use |
Storage And Handling
Other information
- store between 20-25°C (68-77°F)
- do not refrigerate
- store between 20-25°C (68-77°F)
- do not refrigerate
Other information
Inactive Ingredient
Inactive ingredients
organic agave syrup, organic blueberry flavor, natural citrus extract, natural flavor, purified water
Inactive ingredients
organic agave syrup, organic blueberry flavor, organic chamomile extract, natural flavors, purified water
Otc - Questions
Questions? 1-855-436-3921
You may also report side effects to this phone number.
Questions? 1-855-436-3921
You may also report side effects to this phone number.
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
Package Label.Principal Display Panel
Day & Night Combo Pack
Genexa®
MEDICINE MADE CLEAN
Daytime
Maximum Strength
Cough & Chest Congestion
Dextromethorphan HBr - Cough Suppressant
Guaifenesin - Expectorant
Cough
Mucus
Chest Congestion
Nighttime
Severe • Maximum Strength
Nighttime Cold & Flu
Acetaminophen - Pain Reliever/Fever Reducer
Dextromethorphan HBr - Cough Suppressant
Doxylamine Succinate - Antihistamine
Fever
Headache
Sore Throat
Body Aches & Pains
Cough
Sneezing
Runny Nose
Medicine made clean
Same effective active ingredients, but no artificial fillers.
TWO - 6 fl oz (177 mL) bottles | TOTAL - 12 fl oz (355 mL)
* Please review the disclaimer below.
