CVS- childrens stuffy nose and cold solution 
CVS PHARMACY, 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.

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CVS Children's Stuffy Nose and Cold

Drug Facts

Active ingredients (in each 5 mL)

Guaifenesin, USP 100 mg

Phenylephrine HCl, 2.5 mg

Purposes

Expectorant
Nasal Decongestant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
temporarily relieves:
nasal congestion due to a cold
stuffy nose

Warnings

Do not use 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.

Ask a doctor before use if the child has

heart disease
high blood pressure
thyroid disease
diabetes
cough that occurs with too much phlegm (mucus)
persistent or chronic cough such as occurs with asthma

When using this product

 
Do not use more than directed

Stop use and ask a doctor if

your child gets nervous, dizzy or sleepless
symptoms do not get better within 7 days or occur with fever
cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.

These could be signs of a serious illness.

Keep out of reach of children.

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

Directions

do not give more than 6 doses in any 24 hour period
measure only with dosing cup provided
do not use dosing cup with other products
mL= milliliter

Age

Dose

Children 6 years to under 12 years

10 mL every 4 hours

Children 4 years to under 6 years

5 mL every 4 hours

Children under 4 years

do not use

Other information

each 5 mL contains: sodium 3 mg
very low sodium 
store at room temperature
do not refrigerate
dosing cup provided

Inactive ingredients

anhydrous citric acid, edetate disodium, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum.

Questions or Comments?

1-866-467-2748

Package Label-Principal Display Panel 4 FL OZ (118 mL Bottle)

Compare to the Active Ingredients in Children’s Mucinex® Stuffy Nose & Cold

NDC 69842-487-04

Children's Stuffy Nose & Cold Relief

Guaifenesin

Expectorant

Phenylephrine Hcl

Nasal Decongestant

Stuffy Nose
Chest Congestion
Breaks Up Mucus

Dosage Cup Included

For Ages 4 & Over

Dye Free
Mixed Berry Flavor

Naturally and Artificially Flavored

4 FL OZ (118 mL)

TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING

IMPORTANT: Keep this carton for future reference on full labeling.

Distributed by:


CVS Children's Stuffy Nose and Cold Relief Syrup
CVS 
childrens stuffy nose and cold solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-487
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-487-041 in 1 CARTON03/01/2022
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/01/2022
Labeler - CVS PHARMACY, INC (062312574)

Revised: 9/2023
Document Id: 199c6736-a59d-4ef3-8188-640e2621447d
Set id: 6cff265d-94a3-4617-a366-fe970d97f05a
Version: 3
Effective Time: 20230914
 
CVS PHARMACY, INC