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

Winco Foods Childrens Multi Symptom Cold by

Drug Labeling and Warnings

Winco Foods Childrens Multi Symptom Cold by is a Otc medication manufactured, distributed, or labeled by WINCO FOODS, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

Age	Dose
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.

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67091-355
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	5 mg  in 5 mL
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)
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
Color	RED	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67091-355-18	1 in 1 CARTON	03/30/2020
1		118 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/30/2020

Labeler - WINCO FOODS, LLC (056098817)