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

Childrens Multi-Symptom Cold and Fever Relief by

Drug Labeling and Warnings

Childrens Multi-Symptom Cold and Fever Relief 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 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

KEEP OUT OF REACH OF CHILDREN

Uses

• temporarily relieves these common cold and flu symptoms:
• nasal congestion
• stuffy nose
• cough due to minor throat and bronchial irritation
• the intensity of coughing
• the impulse to cough to help your child get to sleep
• minor aches and pains
• sore throat
• headache
• temporarily reduces fever
• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive

Warnings

• Liver warning: This product contains acetaminophen. severe liver damage may occur if your child takes
• more than 5 doses in 24 hours, which is maximum daily amount
• with other drugs containing acetaminophen
• Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, vomiting, consult a doctor promptly.

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

• this product does not contain directions or complete warnings for adult use
• do not take more than directed (see overdose warning)
• shake well before use
• do not take more than 5 doses in any 24 hour period
• if needed, repeat dose every 4 hours while symptoms last
• do not give more than 5 days unless directed by a doctor
• measure only with dosing cup provided
• do not use dosing cup with other products
• dose as follows or as directed by a doctor
• Children 6 to under 12 years of age: 10 mL in dosing cup provided 
• Children under 6 years of age: do not use

Other information

• each 10 mL contains: sodium 10 mg
• store between 15-30oC(59-86oF)
• do not refrigerate
• dosing cup provided

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)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67091-221
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	blue	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67091-221-18	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)