WINCO FOODS CHILDRENS MULTI SYMPTOM COLD- dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride suspension 
WINCO FOODS, LLC

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Winco Mucinex® Children's Multi-Symptom Cold

Drug Facts

Active ingredients
(in each 5 mL)
Purposes

Dextromethorphan HBr 5 mg

Cough suppressant

Guaifenesin 100 mg

Expectorant

Phenylephrine HCl 2.5 mg

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:
cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
the intensity of coughing
the impulse to cough to help your child get to sleep
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

nervousness, dizziness, or sleeplessness occur
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 condition.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 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
dose as follows or as directed by a doctor
AgeDose

children 6 years to under 12 years of age

10 mL every 4 hours

children 4 to under 6 years of age

5 mL every 4 hours

children under 4 years of age

do not use

Other information

each 5 mL contains: sodium 2 mg
store at room temperature
do not refrigerate
use dosing cup provided

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavors, potassium citrate, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions or comments?

1-866-467-2748

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

NDC 67091-355-18
Children's

Multi-Symptom
Cold

Dextromethorphan HBr-Cough Suppressant
Guaifenesin- Expectorant
Phenylephrine HCl - Nasal Decongestant

Relieves Stuffy Nose
Controls Cough
Relieves Chest Congestion
Breaks up Mucus

Dosing Cup Included

For Ages4 & Over

Berry Flavor

Naturally and Artificially Flavored

4 FL OZ (118 mL)

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

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

Distributed by:

*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children’s Mucinex® Multi-Symptom Cold.

Winco Foods Children's Multi Symptom Cold Relief Berry Flavor
WINCO FOODS CHILDRENS MULTI SYMPTOM COLD 
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-355
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide5 mg  in 5 mL
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)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
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:67091-355-181 in 1 CARTON03/30/2020
1118 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01203/30/2020
Labeler - WINCO FOODS, LLC (056098817)

Revised: 12/2023
Document Id: e807e551-1aff-4915-9c9d-378869a15708
Set id: 1d02b32a-e88d-4c70-b66d-7bdc22c25a43
Version: 4
Effective Time: 20231205
 
WINCO FOODS, LLC