CHILDRENS MULTI-SYMPTOM COLD AND FEVER RELIEF- acteaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid 
WinCo Foods, LLC

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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Childrens Multi-Symptom Cold & Fever Relief

Active ingredients (in each 10 mL)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

Warnings

Do not use

  • with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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 giving this product.

Ask a doctor before use if the child has

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

Ask a doctor or pharmacist before use if

you are taking the blood thinning drug warfarin

When using this product
  • do not use more than directed

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 rash or headache. 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Other information

Inactive ingredients

citric acid anhydrous, edetate disodium, FD&C blue 1, FD&C red 40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Questions?

1-800-824-1706 Monday-Friday 9am-4pm MST

You may also report side effects to this phone number.

PDP

*Compare to the active ingredients in  Childrens MUCINEX® Multi-symptom Cold and Fever

Childrens Multi-Symptom Cold and Fever Relief

ACETAMINOPHEN 325 mg per 10 mL /PAIN RELIEVER-FEVER REDUCER

DEXTROMETHORPHAN HBr /COUGH SUPPRESSANT

GUAIFENESIN /EXPECTORANT

PHENYLEPHRINE HCl /NASAL DECONGESTANT

Relieves: Cough, Nasal & Chest Congestion

Thins & Loosens Mucus

Reduces fever

For Ages 6-12 Years

Berry Burst Flavor

4 FL OZ (118 mL)

BOX

CHILDRENS MULTI-SYMPTOM COLD AND FEVER RELIEF 
acteaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-221
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 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)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67091-221-181 in 1 CARTON12/12/2014
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 finalpart34112/12/2014
Labeler - WinCo Foods, LLC (056098817)

Revised: 12/2019
Document Id: d64c27e5-b06f-461c-ae27-b483066eccf9
Set id: 78209395-d854-477e-b097-89a5227638e6
Version: 2
Effective Time: 20191209
 
WinCo Foods, LLC