CHILDRENS MULTI-SYMPTOM COLD- guaifenesin, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid

Childrens Multi-Symptom Cold by

Drug Labeling and Warnings

Childrens Multi-Symptom Cold by is a Otc medication manufactured, distributed, or labeled by Chain Drug Consortium, LLC, AptaPharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• helps to loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passage ways of bothersome mucus and make coughs more productive

• temporarily relieves these symptoms occurring with a cold:

• cough due to minor throat and bronchial irritation

• nasal congestion

• stuffy nose

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

• heart disease

• high blood pressure

• thyroid disease

• diabetes

• cough that occurs with too much phlegm (mucus)

• persistent or chronic cough such as occurs with asthma

When using this product

When using this product

• do not use more than directed

Stop use and ask a doctor

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 condition.

Directions

Directions

• do not take more than 6 doses in any 24-hour period

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

• each 5 mL teaspoon contains: sodium 3 mg

• store between 15-30 ° C (59-86° F)

• do not refrigerate

• dosing cup provided

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

INGREDIENTS AND APPEARANCE

CHILDRENS MULTI-SYMPTOM COLD 
guaifenesin, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-134
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 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)
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
Shape		Size
Flavor	BERRY (VERY BERRY)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-134-00	118 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/27/2012

Labeler - Chain Drug Consortium, LLC (101668460)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(68016-134)