CHILDRENS MULTI-SYMPTOM COLD - guaifenesin, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid 
Chain Drug Consortium, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredients

Drug Facts

Active ingredients

(in each 5 mL teaspoon)

Guaifenesin 100 mg
Dextromethorphan HBr 5 mg
Phenylephrine HCL 2.5 mg

Purpose

Purpose

 Cough suppressant
 Expectorant
 Nasal decongestant

Keep out of reach of children

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control center right away.

Uses

Uses

Warnings

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 two weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or a pharmacist before taking this product.

Ask a doctor before use

Ask a doctor before use if the child has

When using this product


When using this product

Stop use and ask a doctor

Stop use and ask a doctor if

These could be signs of a serious condition.

Directions

Directions

Age                                                                                             Dose
Children 6 years to under 12 years                                                 2 teaspoons every 4 hours
Children 4 years to under 6 years                                                   1 teaspoon every 4 hours
Children under 4 years                                                                  Do not use

Other information

Other information

Inactive ingredients

Inactive ingredients
citric acid anhydrous, D and C red #33,dextrose, FD and C blue #1, FD and C red # 40, flavors, glycerin, maltitol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sucralose, xanthan gum

Questions?

Questions?

Call weekdays from 9:30 AM to 4:30 PM EST at

1-877-798-5944

Product Label

NDC 68016-134-00

*COMPARE TO THE ACTIVE INGREDIENTS IN CHILDREN’S MUCINEX®Multisymptom Cold

Premier Value®
CHILDREN’S MULTI- SYMPTOM COLD

EXPECTORANT
COUGH SUPPRESSANT
NASAL DECONGESTANT

Guaifenesin 100 mg
Dextromethorphan HBr 5 mg
Phenylephrine HCL 2.5 mg

* Stuffy Nose
* Cough
* Chest Congestion
* Breaks up Mucus

Alcohol free

For ages 4 to 12

Very Berry Flavor
4 FL OZ (118mL)

INDEPENDENTLY TESTED SATISFACTION GUARANTEED PV
DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

*This product is not manufactured or distributed by Reckitt Benckiser Inc. distributor of Children’s Mucinex® Multisymptom Cold
If for Any reason you are not satisfied with this product, lease return it to the store where purchased for a full refund.
DISTRIBUTED BY
CHAIN DRUG CONSORTIUM
3301 NW BOCA RATON BLVD
SUITE 101, BOCA RATON, FL 33431
BX-010

AptaPharma hildrens MSCold Label

CHILDRENS MULTI-SYMPTOM COLD 
guaifenesin, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-134
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 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)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
DEXTROSE (UNII: IY9XDZ35W2)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
MALTITOL (UNII: D65DG142WK)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRY (VERY BERRY) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-134-00118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/27/2012
Labeler - Chain Drug Consortium, LLC (101668460)
Registrant - AptaPharma Inc. (790523323)
Establishment
NameAddressID/FEIBusiness Operations
AptaPharma Inc.790523323manufacture(68016-134)

Revised: 2/2013
Document Id: 289ef739-106e-4257-a507-9eaec4b282d4
Set id: e2b7a815-2b12-4e81-af76-1f5680e09acc
Version: 1
Effective Time: 20130228
 
Chain Drug Consortium, LLC