FDA Label for Daytime Severe Cold And Flu

Other

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

Otc - Active Ingredient

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

Otc - Purpose

Purposes

Pain reliever/fever reducer

Cough suppressant

Purposes

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Indications & Usage

Uses

• temporarily reduces fever and relieves these common cold/flu symptoms:
• minor aches and pains
• headache
• sore throat
• cough due to minor throat and bronchial irritation
• controls the impulse to cough to help you get to sleep

Uses

• 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

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

Allergy alert: Acetaminophen may cause severe skin reactions.

Symptoms may include:

• skin reddening
• blisters
• rash

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

• 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

Allergy alert: Acetaminophen may cause severe skin reactions.

Symptoms may include:

• skin reddening
• blisters
• rash

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

• 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 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 an MAOI, ask a doctor or pharmacist before taking this product.

Otc - Ask Doctor

Ask a doctor before use if you have

• liver disease
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Ask a doctor before use if you have

• 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 enlarged prostate gland

Otc - Ask Doctor/Pharmacist

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

• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin

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

• 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.

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). 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.

Dosage & Administration

Directions

• SHAKE WELL before each use
• take only as directed
• only use the dose cup provided
• do not exceed 4 doses per 24 hrs

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

• SHAKE WELL before each use
• take only as directed
• only use the dose cup provided
• do not exceed 4 doses per 24 hours

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

Other information

• store between 20-25°C (68-77°F)
• do not refrigerate

Inactive Ingredient

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

Otc - Questions

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.

Package Label.Principal Display Panel

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