NYQUIL SEVERE VAPOCOOL- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride tablet

NyQuil Severe VapoCool by

Drug Labeling and Warnings

NyQuil Severe VapoCool by is a Otc medication manufactured, distributed, or labeled by JC 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

Doxylmine succinate 6.25 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:  nasal congestion  sinus congestion & pressure  cough due to minor throat & bronchial irritation  cough to help you sleep minor aches & pains headache  fever  sore throat  runny nose & sneezing reduces swelling of nasal passages  temporarily restores freer breathing through the nose  promotes nasal and/or sinus drainage 

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take 

more than 4 doses 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 accompained 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 as MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

liver desease  heart disease  high blood pressure  thyroid disease  diabetes  glaucoma  cough that occurs with too much phlegm (mucus)  a breathing problem or chronic cough that last or as occurs with smoking, asthma, chronic bronchitis, or emphysema  trouble urinating due to enlarged prostate gland 

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

taking the blood thinning drug warfarin.

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 

Stop use and ask a doctor if

you get nervous, dizzy or sleepless  pain, nasal congestion, 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 Posion 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 - see Overdose warning  do not exceed 4 doses 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

When using other DayQuil or NyQuil products, carefully reach each label to ensure correct dosing

Other information

store at room temperature

Questions?

1-800-251-3374 

Inactive ingredients

D&C Yellow No.10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Package Labeling:

New Label:

INGREDIENTS AND APPEARANCE

NYQUIL SEVERE VAPOCOOL 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50269-523
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
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	5 mg

Inactive Ingredients
Ingredient Name	Strength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	green	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	N;Q
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50269-523-22	25 in 1 BOX; Type 0: Not a Combination Product	10/01/2018
2	NDC: 50269-523-20	20 in 1 CARTON	09/30/2019
2		2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/01/2018

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