DAYTIME NIGHTTIME COLD AND COUGH CHILDRENS- dextromethorphan hbr, phenylephrine hcl, diphenhydramine hcl, phenylephrine hcl

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

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Active ingredient:
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Available from:
CVS Pharmacy
Prescription type:
OTC DRUG
Therapeutic indications:
Cough suppressant Nasal decongestant Antihistamine/Cough suppressant Nasal decongestant DAYTIME - temporarily relieves nasal and sinus congestion  cough due to minor throat and bronchial irritation as may occur with a cold - nasal and sinus congestion  - cough due to minor throat and bronchial irritation as may occur with a cold NIGHTTIME -    temporarily relieves sneezing  runny nose  itchy nose or throat  itchy, watery eyes due to hay fever  nasal and sinus congestion  cough due to minor throat and bronchial irritations as may occur with a cold - sneezing  - runny nose  - itchy nose or throat  - itchy, watery eyes due to hay fever  - nasal and sinus congestion  - cough due to minor throat and bronchial irritations as may occur with a cold
Authorization status:
OTC monograph final
Authorization number:
69842-422-08

DAYTIME NIGHTTIME COLD AND COUGH CHILDRENS- dextromethorphan hbr,

phenylephrine hcl, diphenhydramine hcl, phenylephrine hcl

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.

----------

Drug Facts

Active ingredients DayTime (in each 5 mL)

Dextromethorphan HBr 5 mg

Phenylephrine HCl 2.5 mg

Active ingredients for Nighttime (in each 5 mL)

Diphenhydramine HCl 6.25 mg

Phenylephrine HCl 2.5 mg

Purposes for Day Time

Cough suppressant

Nasal decongestant

Purpose for Night Time

Antihistamine/Cough suppressant

Nasal decongestant

Us es

DAYTIME

temporarily relieves

nasal and sinus congestion

cough due to minor throat and bronchial irritation as may occur with a cold

NIGHTTIME

temporarily relieves

sneezing

runny nose

itchy nose or throat

itchy, watery eyes due to hay fever

nasal and sinus congestion

cough due to minor throat and bronchial irritations as may occur with a cold

Warnings

Do not use

DAYTIME

In a child under 4 years of age

In a child who is 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 child's prescription drug contains an MAOI, ask

a doctor or pharmacist before giving this product.

NIGHTTIME

in a child under 4 years of age

in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certan 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 childs prescription drug contains an MAOI, ask

a doctor or pharmacist before giving this product.

with any other product containing diphenhydramine, even one used on skin

for the purpose of making your child sleepy

Ask a doctor before use if the child has

DAYTIME

heart disease

high blood pressure

thyroid disease

diabetes

cough that occurs with too much phlegm (mucus)

chronic cough that lasts, or as occurs with asthma

NIGHTTIME

heart disease

high blood pressure

thyroid disease

diabetes

glaucoma

cough that occurs with too much phlegm (mucus)

chronic cough that lasts, or as occurs with asthma

a breathing problem such as chronic bronchitis

Ask a doctor or pharmacist before use if the child is

NIGHTTIME

taking sedatives or tranquilizers.

When using this product

DAYTIME

do not exceed recommended dosage.

NIGHTTIME

do not exceed recommended dosage

marked drowsiness may occur

excitability may occur, especially in children

sedatives and tranquilizers may increase drowsiness

Stop use and ask a doctor if

DAYTIME

nervousness, dizziness or sleeplessness occur

symptoms do not improve within 7 days or occur with a fever

cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent

headache.

These could be signs of a serious condition.

NIGHTTIME

nervousness, dizziness, or sleeplessness occur

symptoms do not improve within 7 days or occur with a fever

cough persists for more than 7 days, comes back, or occurs with a fever, rash, or persistent

headache.

These could be signs of a serious condition.

Keep out of reach of children.

DAYTIME

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

NIGHTTIME

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away

Directions

DAYTIME

do not give more than 6 doses in any 24-hour period

measure only with dosing cup provided. Do not use any other dosing device.

keep dosing cup with product

mL= milliliter

shake well before using

dose

children 6 to under 12 years of age

10 mL every 4 hours

children 4 to under 6 years of age

5 mL every 4 hours

children under 4 years of age

do not use

NIGHTTIME

Do not give more than 6 doses in 24 hours unless directed by a doctor

measure only with dosing cup provided. Do not use any other dosing device.

keep dosing cup with product

mL= milliliter

shake well before using

dose

children 6 to under 12 years

of age

10 mL every 4 hours

children 4 to under 6 years

of age

do not use unless directed by a

doctor

children under 4 years of

age

do not use

Other information

DAYTIME

each 5 mL contains: sodium 2 mg

store between 20-25ºC (68º-77ºF). Do not refrigerate.

NIGHTTIME

each 5 mL contains: sodium 3 mg

store between 20-25ºC (68-77ºF). Do not refrigerate

protect from light

Inactive ingredients

Inactive ingredients for Day Time

acesulfame potassium, alcohol, benzoic acid, citric acid, disodium EDTA, FD&C red #40, flavor,

maltitol, propylene glycol, purified water, sodium citrate

Inactive ingredients for Night Time

acesulfame potassium, anhydrous citric acid, EDTA disodium, FD&C blue #1, Fd&C red #40, flavor,

maltitol, propylene glycol, purified water, sodium benzoate, trisodium citrate dihydrate

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredients in Children's Triaminic® Day Time Cold & Cough*

Daytime

Children's

Cold & Cough

DEXTROMETHORPHAN HBr Cough suppressant

PHENYLEPHRINE HCl Nasal decongestant

Relieves

Cough

Stuffy nose

Alcohol 0.14%

For Ages 4 to 11 Years

Cherry Flavor

Dosage cup included

FL OZ (mL)

Compare to the active ingredients in Children's Triaminic® Night Time Cold & Cough

Children's

Nighttime Cold & Cough

DIPHENHYDRAMINE HCI Antihistamine; Cough suppressant

PHENYLEPHRINE HCl Nasal decongestant

Relieves

Cough

Runny, stuffy nose

itchy throat

Alcohol free

For Ages 6 to 11 Years

Grape Flavor

Dosage cup included

FL OZ (mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR

UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of

Children's Triaminic® Day Time & Night Time Cold & Cough.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

CVS.com

Product Label

CVS HEALTH Daytime and Nig httime Cold and Coug h

DAYTIME NIGHTTIME COLD AND COUGH CHILDRENS

dextromethorphan hbr, phenylephrine hcl, diphenhydramine hcl, phenylephrine hcl kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 8 42-422

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 8 42-422-0 8

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

0 4/30 /20 18

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

1 BOTTLE

118 mL

Pa rt 2

1 BOTTLE

118 mL

Part 1 of 2

DAYTIME COLD COUGH CHILDRENS

dextromethorphan hbr, phenylephrine hcl liquid

Product Information

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHAN

HYDROBROMIDE

5 mg

in 5 mL

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

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

HYDROCHLORIDE

2.5 mg

in 5 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ACESULFAME PO TASSIUM (UNII: 23OV73Q5G9 )

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

BENZO IC ACID (UNII: 8 SKN0 B0 MIM)

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

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

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

MALTITO L (UNII: D6 5DG142WK)

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

WATER (UNII: 0 59 QF0 KO0 R)

TRISO DIUM CITRATE DIHYDRATE (UNII: B22547B9 5K)

Product Characteristics

Color

S core

S hap e

S iz e

Flavor

CHERRY

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

118 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 MONOGRAPH FINAL

pa rt341

0 4/30 /20 18

Part 2 of 2

NIGHT TIME COLD AND COUGH CHILDREN

diphenhydramine hcl, phenylephrine hcl liquid

Product Information

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DIPHENHYDRAMINE HYDRO CHLO RIDE (UNII: TC2D6 JAD40 ) (DIPHENHYDRAMINE

- UNII:8 GTS8 2S8 3M)

DIPHENHYDRAMINE

HYDROCHLORIDE

6 .25 mg

in 5 mL

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

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

HYDROCHLORIDE

2.5 mg

in 5 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ACESULFAME PO TASSIUM (UNII: 23OV73Q5G9 )

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

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

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

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

MALTITO L (UNII: D6 5DG142WK)

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

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

TRISO DIUM CITRATE DIHYDRATE (UNII: B22547B9 5K)

Product Characteristics

Color

S core

S hap e

S iz e

Flavor

GRAPE

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

118 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 MONOGRAPH FINAL

pa rt341

0 4/30 /20 18

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 4/30 /20 18

CVS Pharmacy

Labeler -

CVS Pharmacy (062312574)

Revised: 5/2019

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