LITTLE COLDS DECONGESTANT PLUS COUGH- dextromethorphan hydrobromide and phenylephrine hydrochloride liquid 
Medtech Products Inc.

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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Little Colds Decongestant Plus Cough

Drug Facts

Active Ingredients

(in each 1.0 mL)

Dextromethorphan HBr 5mg

Purpose

Cough Suppressant

Active Ingredients

(in each 1.0 mL)

Phenylephrine HCI USP 2.5mg

Purpose

Nasal Decongestant

Uses

Temporarily relieves:

Warnings

Do not use:

  • with any other products containing decongestants or cough suppressants. Ask a doctor or pharmacist before using with other drugs if you are not sure.
  • Do not give this product to a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional condition, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you are uncertain whether your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Drug Interaction Precaution: 

Ask a doctor before use if the child has:

  • heart or thyroid disease
  • high blood pressure or diabetes
  • a cough accompanied by excessive phlegm (mucus) or has a persistent or chronic cough such as occurs with asthma

When using this product:

DO NOT EXCEED RECOMMENDED DOSING.

Stop use and ask a doctor if:

  • your child becomes nervous, dizzy or sleepless
  • symptoms do not get better within 7 days, or are accompanied by fever
  • cough persists for more than 7 days, tends to recur, or is accompanied by high fever, rash, or persistent headaches. 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 right away.

Directions

Age (yr)Dose
Under 4Do not use
4 to under 61 mL
6 to under 122 mL

Other Information

Inactive Ingredients:

Citric Acid, Glycerin, High Fructose Corn Syrup, Natural Grape Flavor, Purified Water, Sodium Benzoate and Sucralose

Questions?

Call 1-800-7-LITTLE Mon. – Fri. 8:00 a.m. to 8:00 p.m. EST, or visit us online at www.LittleRemedies.com.

PRINCIPAL DISPLAY PANEL

Little Colds® by Little Remedies®
DECONGESTANT PLUS COUGH
Dextromethorphan/Phenylephrine
RELIEVES STUFF NOSE AND COUGH
1 FL. OZ. (30 mL)

Description: PRINCIPAL DISPLAY PANEL
Little Colds by Little Remedies
Decongestant Plus Cough
1 FL. OZ. (30 mL)

LITTLE COLDS DECONGESTANT PLUS COUGH 
dextromethorphan hydrobromide and phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-402
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 1.0 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1.0 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-402-011 in 1 BOX
130 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34109/01/2010
Labeler - Medtech Products Inc. (122715688)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, Inc.001207208MANUFACTURE

Revised: 10/2010
Document Id: cd299487-04ce-4c42-b402-e16cbb822df1
Set id: f49a3ac0-02ba-4c34-bb78-4818c44af91c
Version: 1
Effective Time: 20101022
 
Medtech Products Inc.