LITTLE COLDS DECONGESTANT PLUS COUGH- dextromethorphan hydrobromide and phenylephrine hydrochloride liquid

Little Colds Decongestant Plus Cough by

Drug Labeling and Warnings

Little Colds Decongestant Plus Cough by is a Otc medication manufactured, distributed, or labeled by Medtech Products Inc., Denison Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 4: Do not use
• 4 to under 6: 1 mL
• 6 to under 12: 2 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)

INGREDIENTS AND APPEARANCE

LITTLE COLDS DECONGESTANT PLUS COUGH 
dextromethorphan hydrobromide and phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-402
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 1.0 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 1.0 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-402-01	1 in 1 BOX
1		30 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	09/01/2010

Labeler - Medtech Products Inc. (122715688)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, Inc.		001207208	MANUFACTURE