DAYQUIL SEVERE PLUS VAPOCOOL COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochl

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

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Active ingredient:
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D), Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS), Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ), Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)
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 - minor aches & pains - headache - fever - sore throat - reduces swelling of nasal passages - temporarily restores freer breathing through the nose - promotes nasal and/or sinus drainage - helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Authorization status:
OTC monograph final
Authorization number:
66715-9904-2, 66715-9904-3, 66715-9904-7

DAYQUIL SEVERE PLUS VAPOCOOL COLD AND FLU- acetaminophen, dextromethorphan

hydrobromide, guaifenesin, and phenylephrine hydrochloride 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.

----------

DayQuil™ 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

Guaifenesin 200 mg

Expectorant

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

minor aches & pains

headache

fever

sore throat

reduces swelling of nasal passages

temporarily restores freer breathing through the nose

promotes nasal and/or sinus drainage

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of

bothersome mucus and make coughs more productive.

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

trouble urinating due to enlarged prostate gland

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.

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

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

each caplet contains: sodium 4 mg

do not exceed 25°C

Inactive ingredients

croscarmellose sodium, crospovidone, FD&C Yellow No. 6 Aluminum Lake, flavor, maltodextrin,

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 - 6 Caplet Pouch Carton

DayQuil™

SEVERE+

VICKS VapoCOOL™

COLD & FLU

Acetaminophen, Phenylephrine HCl,

Dextromethorphan HBr, Guaifenesin

Minor Aches & Pains, Fever

Nasal Congestion & Sinus Pressure

Cough

Chest Congestion

Non-Drowsy

Coated Caplets

Lil'

Drug Store

DAYQUIL SEVERE PLUS VAPOCOOL COLD AND FLU

acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 6 715-9 9 0 4

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

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

Gua ifenesin (UNII: 49 5W7451VQ) (Guaifenesin - UNII:49 5W7451VQ)

Gua ife ne sin

20 0 mg

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

UNII:1WS29 7W6 MV)

Phenylephrine Hydro chlo ride

5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

Cro sca rmello se So dium (UNII: M28 OL1HH48 )

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

FD&C Yello w NO . 6 (UNII: H77VEI9 3A8 )

Ma lto dextrin (UNII: 7CVR7L4A2D)

Micro crysta lline 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)

Sta rch, 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

ORANGE

S core

no sco re

S hap e

OVAL

S iz e

19 mm

Flavor

Imprint Code

Contains

Lil' Drug Store Products, Inc.

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 6 715-9 9 0 4-2

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

2

NDC:6 6 715-9 9 0 4-3

3 in 1 CARTON

0 5/0 1/20 19

2

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

3

NDC:6 6 715-9 9 0 4-7

20 in 1 CARTON

0 5/0 1/20 19

3

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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