CHILDRENS COUGH AND COLD CF - dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid 
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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Drug Facts

Active ingredients (in each 10 mL)

Dextromethorphan HBr, USP 10 mg
Guaifenesin, USP 100 mg
Phenylephrine HCl, USP 5 mg

Purposes

Cough suppressant
Expectorant
Nasal decongestant

Uses

  

  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • temporarily relieves these symptoms occurring with a cold:
  • nasal congestion
  • cough due to minor throat and bronchial irritation

Warnings

Do not use

if your child is now 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 taking this product.

Ask a doctor before use if the child has

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

Ask a doctor or pharmacist before use if child is

taking any other oral nasal decongestant or stimulant.

When using this product do not use more than directed.

Stop use and ask a doctor if

• child gets nervous, dizzy, or sleepless
• symptoms do not get better within 7 days or are accompanied by fever
• cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.
  These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

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

• measure only with dosing cup provided
• keep dosing cup with product
• mL = milliliter
• do not take more than 6 doses in any 24-hour period


 Age
Dose
children under 6 years
do not use
children 6 to under
12 years
10 mL every 4 hours
adults and children
12 years and over
20 mL every 4 hours

Other information

  • each 10 mL contains: sodium 7 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.
  • see bottom panel for number and expiration date

Inactive ingredients

anhydrous citric acid, FD&C red 40 powder, flavor, glycerin, noncrystallizing sorbitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose.

Questions or Comments

1-855-274-4122

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2018 CVS/Pharmacy
CVS.com®  1-800-SHOP CVS
Product of India   V-32402

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ (118 mL Bottle)

CVS
Health

Compare to the
active, ingredients in
Children's Robitussin®
Cough & Cold CF*
Non-drowsy

NDC 59779-984-24

Children's
Cough
& Cold CF

Each 10 mL dose of oral solution contains:

DEXTROMETHORPHAN HBr, USP
10 mg
Cough suppressant
GUAIFENESIN, USP 100 mg
Expectorant
PHENYLEPHRINE HCl, USP 5 mg
Nasal decongestant

Relieves:
•  Cough
•  Chest congestion/mucus
•  Stuffy nose

Alcohol free

For Ages
6 & Over

Grape Flavor
Dosage cup included
Actual Bottle Size on Side panel
4 FL OZ (118 mL)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ (118 mL Bottle)

CHILDRENS COUGH AND COLD CF 
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-984
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 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)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GRAPE (UNII: 6X543N684K)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-984-241 in 1 CARTON06/26/201504/01/2022
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 FINALpart34106/26/201504/01/2022
Labeler - CVS Pharmacy, Inc. (062312574)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurohealth LLC078728447MANUFACTURE(59779-984)

Revised: 11/2020
 
CVS Pharmacy, Inc.