COOLING SEVERE DAYTIME COOLING SEVERE NIGHTTIME- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephri

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), DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Available from:
CVS Pharmacy
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant temporarily relieves common cold/flu symptoms: Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant temporarily relieves common cold/flu symptoms: taking the blood thinning drug warfarin
Authorization status:
OTC monograph final
Authorization number:
69842-182-40, 69842-590-40, 69842-737-02

COOLING SEVERE DAYTIME COOLING SEVERE NIGHTTIME- acetaminophen,

dextromethorphan hydrobromide, doxylamine succinate, phenylephrine

hydrochloride,guaifenesin

CVS Pharmacy

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.

----------

CVS Pharmacy, Inc. Cooling Severe Daytime Cooling Sever Nighttime Drug Facts

Active ingredients (in each 30 mL) – Night Time

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Doxylamine succinate 12.5 mg

Phenylephrine HCl 10 mg

Purpos e

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Us es

temporarily relieves common cold/flu symptoms:

Warnings

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

nasal congestion

sinus congestion and pressure

minor aches and pains

headache

sore throat

runny nose and sneezing

cough to help you sleep

cough due to minor throat and bronchial irritation

reduces swelling of nasal passages

fever

promotes nasal and/or sinus drainage

temporarily restores freer breathing through the nose

more than 4,000 mg of acetaminophen in 24 hours

with other drugs containing acetaminophen

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

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

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

3 or more alcoholic drinks every day while using this product

skin reddening

blisters

rash

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.

if you have ever had an allergic reaction to this product or any of its ingredients

liver disease

heart disease

high blood pressure

thyroid disease

diabetes

glaucoma

cough that occurs with too much phlegm (mucus)

a breathing problem such as emphysema or chronic bronchitis

trouble urinating due to an enlarged prostate gland

persistent or chronic cough such as occurs with smoking, asthma, or emphysema

a sodium-restricted diet

taking sedatives or tranquilizers

taking the blood thinning drug warfarin

do not use more than directed

excitability may occur, especially in children

be careful when driving a motor vehicle or operating machinery

marked drowsiness may occur

Stop use and ask a doctor if

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right

away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you

do not notice any signs or symptoms.

Directions

adults & children 12 yrs & over

30 mL every 4 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Other information

Inactive ingredients

alcohol, anhydrous citric acid, D&C yellow #10, edetate disodium, FD&C blue #1, flavor, glycerin,

polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium

chloride, sodium citrate, sorbitol solution, sucralose

Questions or comments?

1-800-719-9260

alcohol, sedatives, and tranquilizers may increase drowsiness

avoid alcoholic drinks

pain, nasal congestion, or cough gets worse or lasts more than 7 days

you get nervous, dizzy or sleepless

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.

take only as directed – see Overdose warning

only use the dose cup provided

do not exceed 4 doses per 24 hrs

each 30 mL contains: sodium 42 mg

store at 20-25 C (68-77 F)

Active ingredients (in each 30 mL) - Day Time

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Purpos e

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Us es

temporarily relieves common cold/flu symptoms:

Warnings

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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

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.

nasal congestion

sinus congestion and pressure

cough due to minor throat and bronchial irritation

minor aches and pains

headache

fever

reduces swelling of nasal passages

temporarily restores freer breathing through the nose

sore throat

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

bothersome mucus and make coughs more productive

promotes nasal and/or sinus drainage

more than 4,000 mg of acetaminophen in 24 hours

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product

skin reddening

blisters

rash

Do not use

Ask a doctor before use if you have

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

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right

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.

if you have ever had an allergic reaction to this product or any of its ingredients

liver disease

heart disease

thyroid disease

high blood pressure

trouble urinating due to an 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

diabetes

a sodium-restricted diet

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.

away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you

do not notice any signs or symptoms.

Directions

adults & children 12 yrs & over

30 mL every 4 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Other information

Inactive ingredients

alcohol, anhydrous citric acid, D&C yellow #10, edetate disodium, FD&C blue #1, flavor, glycerin,

polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium

chloride, sodium citrate, sorbitol solution, sucralose

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to the active ingredients in Vicks

DayQuil

Severe+VapoCOOL

Cooling

Severe Daytime

COLD & FLU RELIEF

ACETAMINOPHEN – Pain reliever/Fever reducer

PHENYLEPHRINE HCl – Nasal decongestant

DEXTROMETHORPHAN HBr – Cough suppressant

GUAIFENESIN – Expectorant

Relieves:

Minor aches, pains & fever

Nasal congestion & sinus pressure

Cough

Chest congestion

ALCOHOL 10%

take only as directed – see Overdose warning

only use the dose cup provided

do not exceed 4 doses per 24 hrs

each 30 mL contains: sodium 41 mg

store at 20-25 C (68-77 F). Do not refrigerate.

12 FL OZ (355 mL)

Compare to the active ingredients in Vicks

NyQuil

Severe+VapoCOOL

Cooling

Severe Nighttime

COLD & FLU RELIEF

ACETAMINOPHEN – Pain reliever/Fever reducer

PHENYLEPHRINE HCl – Nasal decongestant

DOXYLAMINE SUCCINATE - Antihistamine

DEXTROMETHORPHAN HBr – Cough suppressant

Relieves:

Minor aches, pains & fever

Nasal congestion & sinus pressure

Sneezing, runny nose

Cough

ALCOHOL 10%

12 FL OZ (355 mL)

COOLING SEVERE DAYTIME COOLING SEVERE NIGHTTIME

acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride,guaifenesin

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 8 42-737

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 8 42-737-0 2

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

0 7/23/20 19

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

1 BOTTLE

355 mL

Pa rt 2

1 BOTTLE

355 mL

Part 1 of 2

Part 1 of 2

COOLING SEVERE NIGHTTIME

acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride solution

Product Information

Ite m Code (Source )

NDC:6 9 8 42-59 0

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

6 50 mg

in 30 mL

DEXTRO METHO RPHAN HYDRO BRO MIDE (UNII: 9 D2RTI9 KYH)

(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHAN

HYDROBROMIDE

20 mg

in 30 mL

DO XYLAMINE SUCCINATE (UNII: V9 BI9 B5YI2) (DOXYLAMINE -

UNII:9 5QB77JKPL)

DOXYLAMINE SUCCINATE

12.5 mg

in 30 mL

PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE -

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

HYDROCHLORIDE

10 mg

in 30 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

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

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

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

GLYCERIN (UNII: PDC6 A3C0 OX)

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

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

SO DIUM CITRATE, UNSPECIFIED FO RM (UNII: 1Q73Q2JULR)

SO RBITO L (UNII: 50 6 T6 0 A25R)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 8 42-59 0 -40

355 mL in 1 BOTTLE; 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 mo no graph final

pa rt341

0 6 /20 /20 19

Part 2 of 2

COOLING SEVERE DAYTIME

acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solution

Product Information

Ite m Code (Source )

NDC:6 9 8 42-18 2

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

6 50 mg

in 30 mL

DEXTRO METHO RPHAN HYDRO BRO MIDE (UNII: 9 D2RTI9 KYH)

(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHAN

HYDROBROMIDE

20 mg

in 30 mL

GUAIFENESIN (UNII: 49 5W7451VQ) (GUAIFENESIN - UNII:49 5W7451VQ)

GUAIFENESIN

40 0 mg

in 30 mL

PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE -

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

HYDROCHLORIDE

10 mg

in 30 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

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

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

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

GLYCERIN (UNII: PDC6 A3C0 OX)

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

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

SO DIUM CITRATE, UNSPECIFIED FO RM (UNII: 1Q73Q2JULR)

SO RBITO L (UNII: 50 6 T6 0 A25R)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 8 42-18 2-40

355 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

CVS Pharmacy

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

0 6 /20 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

0 7/23/20 19

Labeler -

CVS Pharmacy (062312574)

Revised: 1/2020

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