NIGHTTIME COLD AND COUGH CHILDRENS- diphenhydramine hcl, phenylephrine hcl liquid

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

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Active ingredient:
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Available from:
CVS Pharmacy
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antihistamine/Cough suppressant Nasal decongestant - 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:
69842-379-04

NIGHTTIME COLD AND COUGH CHILDRENS- diphenhydramine hcl, phenylephrine

hcl liquid

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 (in each 5 mL)

Diphenhydramine HCl 6.25 mg

Phenylephrine HCl 2.5 mg

Purpos es

Antihistamine/Cough suppressant

Nasal decongestant

Us es

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

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.

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

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

taking sedatives or tranquilizers

When using this product,

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

nervousness, dizziness or sleeplessness occurs

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

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

These could be signs of a serious condition.

Keep out of reach of children.

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

Directions

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

do not use

Other Information

each 5 mL contains: sodium 3 mg

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

protect from light

Inactive ingredients

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

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

FL OZ (mL)

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

UNDER THE CAP IS BROKEN OR MISSING.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

CVS.com

Package Label

CVS HEALTH Children's Nig httime Cold & Coug h

NIGHTTIME COLD AND COUGH CHILDRENS

diphenhydramine hcl, phenylephrine hcl liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 8 42-379

Route of Administration

ORAL

CVS Pharmacy

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 )

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

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

MALTITO L (UNII: D6 5DG142WK)

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

WATER (UNII: 0 59 QF0 KO0 R)

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

TRISO DIUM CITRATE DIHYDRATE (UNII: B22547B9 5K)

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

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

NDC:6 9 8 42-379 -

118 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

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

Labeler -

CVS Pharmacy (062312574)

Revised: 5/2019

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