Active Ingredients
(in each 1.0 mL)
Dextromethorphan HBr 5mg
(in each 1.0 mL)
Phenylephrine HCI USP 2.5mg
Little Colds Decongestant Plus Cough
FDA Label NDC 63029-402
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Medtech Products Inc. for the product Little Colds Decongestant Plus Cough (NDC 63029-402). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, do not use:, ask a doctor before use if the child has:, when using this product:, stop use and ask a doctor if:, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Cough Suppressant
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
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)
Description: Principal Display Panellittle Colds By Little Remediesdecongestant Plus Cough1 Fl. Oz. (30 mL) (Little Colds Decongestant Plus Cough 01)
* Please review the disclaimer below.
