DAYQUIL SEVERE VAPOCOOL COLD AND FLU- acetaminophen, dextromethorphan hydrobromide tablet, coated

DayQuil Severe VapoCool Cold and Flu by

Drug Labeling and Warnings

DayQuil Severe VapoCool Cold and Flu by is a Otc medication manufactured, distributed, or labeled by J.C. World Bell Wholesale Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each caplet)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg

Purpose

Pain reliever/Fever reducer
Cough suppressant

Uses

temporarily relieves common cold/flu symptoms:  cough due to minor throat & bronchial irritation  sore throat  headache  minor aches & pains  fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 caplets in 24 hrs, 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, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

take only as directed do not exceed 8 caplets per 24 hrs
adults & children 12 yrs & over. 2 caplets with water every 4 hrs
children 4 to under 12 yrs. ask a doctor
children under 4 yrs. do not use

Other information

store at no greater than 25°C (77°F)

Inactive ingredients

corn starch, crospovidone, FD&C Yellow No. 6 Aluminum Lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide

Package Labeling:

INGREDIENTS AND APPEARANCE

DAYQUIL SEVERE VAPOCOOL COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50269-554(NDC:84126-352)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
CROSPOVIDONE (UNII: 2S7830E561)
FD&C YELLOW NO. 6 ALUMINUM LAKE (UNII: GYP6Z2JR6Q)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL (UNII: 532B59J990)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	DQV
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50269-554-01	6 in 1 BOX	05/06/2025
1		1 in 1 BLISTER PACK
1		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	05/06/2025

Labeler - J.C. World Bell Wholesale Co., Inc. (805257581)

Registrant - J.C. World Bell Wholesale Co., Inc. (805257581)