CHILDRENS COLD, COUGH AND SORE THROAT - acetaminophen, guaifenesin, dextromethorphan hbr, phenylephrine hcl 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 10 mL or 2 teaspoons)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCL 5 mg

Purpose

Purpose

Pain reliever/fever reducer
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

Warnings

Liver warning: This product contains acetaminophen. Sever liver damage may occur if your child if your child takes


Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

Do not use

Ask a doctor before use if your child has



Ask a doctor or pharmacist before use if

Stop use and ask a doctor if


These could be signs of a serious condition.

Directions

Directions



Age                                                                       Dose
Children 6 to under 12 years of age                          2 teaspoonfuls
Children under 6 years of age                                  do not use

Other information

Overdose warning

When using this product

Inactive ingredients

anhydrous citric acid,edetate disodium,  FD and C Blue #1, FD and C Red # 40, flavors, glycerin, propylene glycol, propyl gallate, purified water,  sodium benzoate, sorbitol, sucralose, xanthan gum

Questions?

 1-877-798-5944

Product Label

NDC 68016-224-00

COMPARE TO THE ACTIVE INGREDIENTS IN CHILDREN’S MUCINEX® COLD, COUGH, and SORE THROAT LIQUID

Premier Value®
Children's Cold, Cough, and Sore Throat

Acetaminophen / Guaifenesin / Dextromethorphan HBr / Phenylephrine HCL

PAIN RELIEVER / FEVER REDUCER
EXPECTORANT
COUGH SUPPRESSANT
NASAL DECONGESTANT

Guaifenesin 100 mg
Dextromethorphan HBr 5 mg
Phenylephrine HCL 2.5 mg

    * Cough
    * Sore Throat
    * Nasal Congestion
    * Chest Congestion


For ages 6 to 12

Mixed Berry Flavor
4 FL OZ (118mL)

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

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® Cold, Cough and Sore Throat Liquid
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
BX028

AptaPharma ChildColdCoughSoreThroat  Label

CHILDRENS COLD, COUGH AND SORE THROAT 
acetaminophen, guaifenesin, dextromethorphan hbr, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-224
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
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)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRY (MIXED BERRY) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-224-00118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/01/2013
Labeler - Chain Drug Consortium, LLC (101668460)
Registrant - AptaPharma Inc. (790523323)
Establishment
NameAddressID/FEIBusiness Operations
AptaPharma Inc.790523323manufacture(68016-224)

Revised: 4/2013
Document Id: 7c8f6aa5-051e-413c-97e1-480a66e7b0cd
Set id: b3cd548b-9b49-4dac-bd0f-30ee71bacb3f
Version: 1
Effective Time: 20130412
 
Chain Drug Consortium, LLC