CHILDRENS MULTI-SYMPTOM COLD- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Childrens Multi-symptom Cold by

Drug Labeling and Warnings

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]

Active ingredients (in each 5 mL)

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

Phenylephrine HCl 2.5 mg

Purpose

Cough suppressant

Expectorant

Nasal decongestant

KEEP OUT OF REACH OF CHILDREN

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
• temporarily relieves:
• cough due to minor throat and bronchial irritation as may occur with a 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 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
• persistent or chronic cough such as occurs with asthma
• cough that occurs with too much phlegm (mucus)

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.

Directions

• do not take 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: 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: potassium 5 mg, sodium 5 mg
• store between 15-30oC (59-86oF)
• do not refrigerate
• dosing cup provided

Inactive ingredients

citric acid anhydrous, D&C red 33, dextrose, edetate disodium, FD&C blue 1, FD&C red 40, flavor, glycerin, methylparaben, potassium sorbate, propyl gallate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sorbitol solution, 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 Children's MUCINEX® Multi-symptom cold

Children's Multi-symptom Cold Relief

Dextromethorphan HBr / Cough suppressant

Guaifenesin / Expectorant

Phenylephrine HCl / Nasal decongestant

Relieves:Stuffy Nose, Cough, Chest Congestion

Thins and Loosens Mucus

For Ages 4-12 Years

Ver Berry Flavor

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

CHILDRENS MULTI-SYMPTOM COLD 
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67091-220
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)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
DEXTROSE (UNII: IY9XDZ35W2)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYL GALLATE (UNII: 8D4SNN7V92)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
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: 67091-220-18	1 in 1 CARTON	12/12/2014
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 final	part341	12/12/2014

Labeler - WinCo Foods, LLC (056098817)