Little Colds Decongestant Plus Cough

Dosage form: liquid
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 5mg in 1.0mL, PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 1.0mL
Labeler: Medtech Products Inc.
NDC Code: 63029-402

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.

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:

  • cough due to minor throat & bronchial irritation as may occur with the common cold
  • nasal congestion due to the common cold, hay fever or other respiratory allergies

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
  • Give this medicine by mouth only.
  • Only use the enclosed dropper. Do not use any other dropper, spoon or dosing device when giving this medicine to your child.
  • Fill the enclosed dropper to the prescribed level and slowly dispense the liquid into your child’s mouth (towards the inner cheek).
  • Do not give more than 6 doses in any 24-hour period (see overdose warning).
  • If needed, repeat dose every 4 hours or as directed by a doctor.
Age (yr)Dose
Under 4Do not use
4 to under 61 mL
6 to under 122 mL

Other Information
  • Store at 20-25°C (68-77°F)
  • Protect from moisture.
  • Oral dosing device enclosed.
  • Tamper Evident: This product has a foil seal under the cap. Do not use if broken or missing.
  • Check expiration date on bottle or box before using.

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)

LITTLE COLDS DECONGESTANT PLUS COUGH 
dextromethorphan hydrobromide and phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-402
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 1.0 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1.0 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
WATER 
SODIUM BENZOATE 
SUCRALOSE 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63029-402-011 BOTTLE, DROPPER (1 BOTTLE) 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/FEIOperations
Denison Pharmaceuticals, Inc.001207208MANUFACTURE

Revised: 10/2010
 
Medtech Products Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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