CVS CHILDRENS NIGHTTIME MULTI SYMPTOM COLD- acetaminophen , diphenhydramine hydrochloride,phenylephrine hydrochloride liquid 
CVS PHARMACY

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CVS Children’s Nighttime Multi-Symptoms Cold 4 FL OZ (180 mL)

Drug Facts

Active ingredients (in each 10 mL)Purposes

Acetaminophen 325 mg

Pain reliever/fever reducer

Diphenhydramine HCl 12.5 mg

Antihistamine/cough suppressant

Phenylephrine HCl 5 mg

Nasal decongestant

Uses

temporarily relieves these common cold and flu symptoms:
cough
nasal congestion
minor aches and pains
sore throat
headache
runny nose
sneezing
temporarily reduces fever
controls cough to help you get to sleep

Warnings

Liver Warning:

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

more than 5 doses in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen

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.
To make child sleepy
with any other drug containing diphenhydramine, even one used on the skin
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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if the child have

liver disease
heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
a breathing problem such as chronic bronchitis
persistent or chronic cough such as occurs with asthma
cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if the child is

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

When using this product

do not use more than directed (see Overdose warning)
excitability may occur, especially in children
marked drowsiness may occur
sedatives and tranquilizers may increase drowsiness

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur
pain, nasal congestion, or cough gets worse or lasts more than 5 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

Keep out of reach of children.

Overdose warning:

Taking more than the recommended dose (overdose) may cause liver damage. 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

this product does not contain directions or complete warnings for adult use
do not give more than directed (see Overdose warning)
measure only with dosing cup provided
do not use dosing cup with other products
dose as follows or as directed by a doctor
children 6 years to 12 years of age: 10 mL in dosing cup provided every 4 hours while symptoms last; do not give more than 5 doses in 24-hours period
children under 6 years of age: do not use

Other information

each 10 mL contains: sodium 4 mg
store at room temperature
do not refrigerate

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, natural and artificial flavor, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Questions or comments?

1-866-467-2748

PRINCIPAL DISPLAY PANEL

Compare to the active ingredients in Children’s Mucinex® Night Time Multi-Symptom Cold

NDC# 51316-733-04

Children’s

Night TimeMuti-Symptom Cold

 
Acetaminophen Pain Reliever/Fever Reducer
Diphenhydramine HCl Antihistamine/Cough Suppressant
Phenylephrine HCl Nasal Decongestant

Relieves Stuffy Nose

Controls Cough

Relieves Fever & Sore Throat

Relieves Runny Nose & Sneezing

Dosing Cup Included

For Ages 6 & Over

Very Berry Flavor

Naturally and Artificially Flavored

4 FL OZ (118 mL) 

*This product is not manufactured or distributed by RB Health (US), distributor Children’s Mucinex® Nighttime Multi-Symptoms Cold..

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING.

Distributed by:

CVS Children's Nighttime Multi-Symptoms Cold 4fl oz 118 mL
CVS CHILDRENS NIGHTTIME MULTI SYMPTOM COLD 
acetaminophen , diphenhydramine hydrochloride,phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-733
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 10 mL
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51316-733-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product02/20/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01002/20/2023
Labeler - CVS PHARMACY (062312574)

Revised: 11/2023
Document Id: d18e8414-311e-49dc-a459-817445af3d76
Set id: 9b244ac8-4ca7-43a0-b328-88f15f0fcc9d
Version: 3
Effective Time: 20231102
 
CVS PHARMACY