DAYTIME SEVERE COLD AND FLU- acetaminophen, dextromethorphan hbr suspension

Daytime Severe Cold and Flu by

Drug Labeling and Warnings

Daytime Severe Cold and Flu by is a Otc medication manufactured, distributed, or labeled by Genexa Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DO NOT use if seal under the cap is disturbed or missing.

Drug Facts

ACTIVE INGREDIENT

Active ingredients

(in each 20 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

PURPOSE

Purposes

Pain reliever/fever reducer

Cough suppressant

INDICATIONS & USAGE

Uses

• temporarily reduces fever and relieves these common cold/flu symptoms:
• minor aches and pains
• headache
• cough due to minor throat and bronchial irritation

• controls the impulse to cough to help you get to sleep

SPL UNCLASSIFIED SECTION

SHAKE WELL before each use.

Distributed by: Genexa Inc., Atlanta, GA 30324 |

genexa.com | U.S. Patent No. 11,617,795

Made in the USA with globally sourced ingredients

NDC: 69676-0093-9

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.

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.

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

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

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.

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.

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

STORAGE AND HANDLING

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

QUESTIONS

Questions? 1-855-436-3921

You may also report side effects to this phone number

PRINCIPAL DISPLAY PANEL

Maximum Strength

Genexa®

MEDICINE MADE CLEAN

Severe Cold & Flu

Acetaminophen - Pain Reliever/Fever Reducer

Dextromethorphan HBr - Cough Suppressant

Fever

Headache

Body Aches & Pains

Sore Throat

Cough

Medicine made clean

Same effective active ingredients, but no artificial fillers.

6 fl oz (177 mL)

Organic Blueberry Flavor

INGREDIENTS AND APPEARANCE

DAYTIME SEVERE COLD AND FLU 
acetaminophen, dextromethorphan hbr suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69676-0093
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 20 mL
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
AGAVE TEQUILANA JUICE (UNII: GVG8G0207O)
XYLITOL (UNII: VCQ006KQ1E)
BLUEBERRY (UNII: 253RUG1X1A)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	brown (Light)	Score
Shape		Size
Flavor	BLUEBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69676-0093-9	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/03/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	07/03/2024

Labeler - Genexa Inc. (079751024)