Cold (Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl) Liquid [Cvs Pharmacy] -

COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [CVS PHARMACY]
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NDC	69842-570-88
Set ID	eaa07dd4-cb7e-45ca-abe4-7a3f7a9d928d
Category	HUMAN OTC DRUG LABEL
Packager	CVS PHARMACY
Generic Name
Product Class	alpha-1 Adrenergic Agonist
Product Number
Application Number	PART341

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Active ingredients (in each 5 mL)

Dextromethorphan HBr 5 mg
Guaifenesin 100 mg
Phenylephrine HCl 2.5 mg
Purpose

Cough suppressant
Expectorant
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
  - stuffy nose
  - nasal congestion due to a cold
  - the intensity of coughing
  - the impulse to cough to help the child get to sleep
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
- diabetes
- heart disease
- thyroid disease
- high blood pressure
- persistent or chronic cough such as occurs with asthma
- cough that occurs with too much phlegm (mucus)
When using this product

do not exceed recommended dosage.
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 persists more than 7 days, tends to recur, or is accompanied by a 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 (1-800-222-1222) right away.
Directions
- mL = milliliter; FL OZ = fluid ounce
- use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
- dose as follows or as directed by a doctor
- do not take more than 6 doses in any 24-hour period
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: sodium 3 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive ingredients

anhydrous citric acid, FD&C red # 40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose, xanthan gum
Questions or comments?

1-800-426-9391
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VALUE SIZE

♥︎CVS
Health™

Compare to the active ingredients in Children's Mucinex® Multi-Symptom Cold*

Children's
Multi-Symptom
Cold

DEXTROMETHORPHAN HBr
Cough suppressant
GUAIFENESIN
Expectorant
PHENYLEPHRINE HCl
Nasal decongestant

Relieves:
• Stuffy nose
• Cough
• Chest congestion

Breaks up mucus
Alcohol free

For Ages 4
to 11 Years

Very Berry Flavor
Dosage cup included
Actual Bottle Size on Side Panel

6.8 FL OZ (201 mL)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Reckitt Benckiser LLC, owner of the registered trademark Children's Mucinex® Multi-Symptom Cold.

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2018 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
V-19849

CVS®Quality
Money Back Guarantee

50844 ORG031805788

CVS 44-057

INGREDIENTS AND APPEARANCE

COLD CHILDRENS, MULTI SYMPTOM
dextromethorphan hbr, guaifenesin, phenylephrine hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-570
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69842-570-88	1 in 1 CARTON	07/31/2018
1		201 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	07/31/2018

Labeler - CVS PHARMACY (062312574)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	manufacture(69842-570) , pack(69842-570)

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Medic

COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [CVS PHARMACY]

Do not use

Ask a doctor before use if the child has

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

Related Drugs

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