CVS- childrens stuffy nose and cold solution

CVS by

Drug Labeling and Warnings

CVS by is a Otc medication manufactured, distributed, or labeled by CVS PHARMACY, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 usein 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:

INGREDIENTS AND APPEARANCE

CVS 
childrens stuffy nose and cold solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-487
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	pink	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-487-04	1 in 1 CARTON	03/01/2022
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	03/01/2022

Labeler - CVS PHARMACY, INC (062312574)