Daytime And Nighttime Severe Cold & Flu Combo Pack

Daytime And Nighttime Severe Cold & Flu Combo Pack
SPL v2
SPL
SPL Set ID 190c7eaf-dcd4-d314-e063-6294a90a6f33
Route
ORAL
Published
Effective Date 2024-09-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Dextromethorphan (20 mg) Doxylamine (30 mg)
Inactive Ingredients
Agave Tequilana Juice Water Xylitol Blueberry Chamomile

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-03

Description

Daytime Severe Cold & Flu Drug Facts


Medication Information

Warnings and Precautions

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.

Indications and 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
Dosage and 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

Description

Daytime Severe Cold & Flu Drug Facts

Section 42229-5

Daytime Severe Cold & Flu

Drug Facts

Section 44425-7

Other information

  • store between 20-25°C (68-77°F)
  • do not refrigerate
Section 50565-1

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.

Section 50566-9

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.

Section 50567-7

When using this product, do not use more than directed.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Section 50569-3

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
Section 50570-1

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.
Section 51727-6

Inactive ingredients

organic agave syrup, organic blueberry flavor, natural flavors, purified water, xylitol

Section 51945-4

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

Section 53413-1

Questions? 1-855-436-3921

You may also report side effects to this phone number.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purposes

Pain reliever/fever reducer

Cough suppressant

Section 55106-9

Active ingredients (in each 20 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg


Structured Label Content

Indications and Usage (34067-9)

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
Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

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.

Section 42229-5 (42229-5)

Daytime Severe Cold & Flu

Drug Facts

Section 44425-7 (44425-7)

Other information

  • store between 20-25°C (68-77°F)
  • do not refrigerate
Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

When using this product, do not use more than directed.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Section 50569-3 (50569-3)

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
Section 50570-1 (50570-1)

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.
Section 51727-6 (51727-6)

Inactive ingredients

organic agave syrup, organic blueberry flavor, natural flavors, purified water, xylitol

Section 51945-4 (51945-4)

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

Section 53413-1 (53413-1)

Questions? 1-855-436-3921

You may also report side effects to this phone number.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purposes

Pain reliever/fever reducer

Cough suppressant

Section 55106-9 (55106-9)

Active ingredients (in each 20 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg


Advanced Ingredient Data


Raw Label Data

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