The following Structured Product Label (SPL) was submitted to the FDA by Genexa Inc. for the product Daytime Severe Cold And Flu (NDC 69676-0093). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Daytime Severe Cold & Flu
Drug Facts
Nighttime Severe Cold & Flu
Drug Facts
Tamper evident: Do not use if seal under the cap is disturbed or missing.
SHAKE WELL before each use.
U.S. Patent No. 11,617,795 | Distributed by: Genexa Inc. Atlanta, GA 30324 | genexa.com
Made in the USA with globally sourced ingredients
NDC 69676-0095-3
Active ingredients (in each 20 mL)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Active ingredients (in each 20 mL)
Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine Succinate 12.5 mg
Purposes
Pain reliever/fever reducer
Cough suppressant
Purposes
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Uses
Uses
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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.
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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.
Do not use
Do not use
Ask a doctor before use if you have
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Ask a doctor or pharmacist before use if you are
When using this product, do not use more than directed.
When using this product
Stop use and ask a doctor if
These could be signs of a serious condition.
Stop use and ask a doctor if
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
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 (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.
Keep out of reach of children.
In case of overdose, get medical help or contact 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.
Directions
| adults & children 12 yrs & over | 20 mL every 4 hours |
| children 4 to under 12 yrs | ask a doctor |
| children under 4 yrs | do not use |
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 |
Other information
Other information
Inactive ingredients
organic agave syrup, organic blueberry flavor, natural flavors, purified water, xylitol
Inactive ingredients
organic agave syrup, organic blueberry flavor, organic chamomile extract, natural flavors, purified water
Questions? 1-855-436-3921
You may also report side effects to this phone number.
Questions? 1-855-426-3921
You may also report side effects to this phone number.
Day & Night Combo Pack
Genexa®
MEDICINE MADE CLEAN
Daytime
Maximum Strength
Severe Cold & Flu
Acetaminophen - Pain Reliever/Fever Reducer
Dextromethorphan HBr - Cough Suppressant
Fever
Headache
Body Aches & Pains
Sore Throat
Cough
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)
Organic Blueberry Flavor
* Please review the disclaimer below.
