NYQUIL SEVERE PLUS VAPOCOOL COLD AND FLU- acetaminophen, phenylephrine hydrochloride, doxylamine succinate, and dextromethorphan

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D), Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV), Doxylamine Succinate (UNII: V9BI9B5YI2) (Doxylamine - UNII:95QB77JKPL), Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS)
Available from:
Lil' Drug Store Products, Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
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
Authorization status:
OTC monograph final
Authorization number:
66715-9905-2

NYQUIL SEVERE PLUS VAPOCOOL COLD AND FLU- acetaminophen, phenylephrine

hydrochloride, doxylamine succinate, and dextromethorphan hydrobromide tablet, coated

Lil' Drug Store Products, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

NyQuil™ Severe+ VapoCOOL™ Cold & Flu

Drug Facts

Active ingredients (in each

caplet)

Purpose

Acetaminophen 325 mg

Pain reliever/fever

reducer

Dextromethorphan HBr 10 mg

Cough suppressant

Doxylamine succinate 6.25 mg

Antihistamine

Phenylephrine HCl 5 mg

Nasal decongestant

Us es

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 8 caplets 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

heart disease

high blood pressure

thyroid disease

diabetes

glaucoma

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

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 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

do not exceed 25°C

Inactive ingredients

crospovidone, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue

No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, flavor, magnesium stearate,

microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch,

silicon dioxide, stearic acid, sucralose, talc, titanium dioxide

Ques tions ?

1-800-362-1683

Product repackaged and distributed with permission of manufacturer by:

Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404

PRINCIPAL DISPLAY PANEL - 4 Caplet Pouch Carton

NyQuil™

SEVERE+

VICKS VapoCOOL™

COLD & FLU

Acetaminophen, Phenylephrine HCl,

Doxylamine Succinate, Dextromethorphan HBr

Minor Aches & Pains, Fever

Nasal Congestion & Sinus Pressure

Sneezing, Runny Nose

Cough

Nighttime Relief

Coated Caplets

Lil'

DrugStore

NYQUIL SEVERE PLUS VAPOCOOL COLD AND FLU

acetaminophen, phenylephrine hydrochloride, doxylamine succinate, and dextromethorphan hydrobromide tablet,

coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 6 715-9 9 0 5

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Aceta mino phen (UNII: 36 2O9 ITL9 D) (Acetamino phen - UNII:36 2O9 ITL9 D)

Ac e ta mino phe n

325 mg

Phenylephrine Hydro chlo ride (UNII: 0 4JA59 TNSJ) (Phenylephrine -

UNII:1WS29 7W6 MV)

Phenylephrine Hydro chlo ride

5 mg

Do xyla mine Succina te (UNII: V9 BI9 B5YI2) (Do xylamine - UNII:9 5QB77JKPL)

Do xylamine Succinate

6 .25 mg

Dextro metho rpha n Hydro bro mide (UNII: 9 D2RTI9 KYH) (Dextro metho rphan -

UNII:7355X3ROTS)

De xtro me tho rpha n

Hydro bro mide

10 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CRO SPO VIDO NE ( 15 MPA.S AT 5%) (UNII: 6 8 40 19 6 0 MK)

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

FD&C BLUE NO . 2 (UNII: L0 6 K8 R7DQK)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

Ma g nesium Stea ra te (UNII: 70 0 9 7M6 I30 )

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

PO LYVINYL ALCO HO L, UNSPECIFIED (UNII: 532B59 J9 9 0 )

PO VIDO NE, UNSPECIFIED (UNII: FZ9 8 9 GH9 4E)

STARCH, CO RN (UNII: O8 232NY3SJ)

Silico n Dio xide (UNII: ETJ7Z6 XBU4)

Stea ric Acid (UNII: 4ELV7Z6 5AP)

Sucra lo se (UNII: 9 6 K6 UQ3ZD4)

Ta lc (UNII: 7SEV7J4R1U)

Tita nium Dio xide (UNII: 15FIX9 V2JP)

Product Characteristics

Color

GREEN

S core

no sco re

S hap e

OVAL

S iz e

19 mm

Lil' Drug Store Products, Inc.

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 6 715-9 9 0 5-2

2 in 1 CARTON

0 5/0 1/20 19

1

2 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt341

0 5/0 1/20 19

Labeler -

Lil' Drug Store Products, Inc. (093103646)

Revised: 5/2019

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