Little Colds Multi Symptom Cold

Dosage form: liquid
Ingredients: ACETAMINOPHEN 80mg in 1.0mL, DEXTROMETHORPHAN HYDROBROMIDE 2.5mg in 1.0mL, PHENYLEPHRINE HYDROCHLORIDE 1.25mg in 1.0mL
Labeler: Medtech Products Inc.
NDC Code: 63029-404

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 Multi Symptom Cold Formula

Drug Facts

Active ingredient

(in each 1.0 mL)

Acetaminophen 80 mg

Purpose

Pain reliever/fever reducer

Active ingredient

(in each 1.0 mL)

Dextromethorphan HBr 2.5mg

Purpose

Cough Suppressant

Active ingredient

(in each 1.0 mL)

Phenylephrine HCI USP 1.25 mg

Purpose

Nasal Decongestant

Uses

Temporarily: 

  • relieves minor aches and pains which may be associated with the common cold, sore throat or headache
  • reduces fever
  • relieves cough and nasal congestion due to minor throat/bronchial irritation, the common cold, hay fever or other respiratory allergies

Warnings

Liver warning: This product contains acetaminophen. Sever liver damage may occur if your child takes:

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen

Ask a doctor before use

if your child has liver disease.

Ask a doctor or pharmacist before use

if your child is taking the blood thinning drug warfarin.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

Do not use
  • with any other products containing acetaminophen, decongestants or cough suppressants (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist before using with other drugs.

Drug Interaction Precaution:

Do not give this product to 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 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.

Ask a doctor before use if your child has
  • liver, 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 EXCEEED RECOMMENDED DOSAGE.

Stop use and ask a doctor if
  • your child becomes nervous, dizzy or sleepless
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • pain, cough or nasal congestion gets worse or lasts more than 5 days
  • cough tends to recur or is accompanied by high fever, rash or persistent headaches
  • redness or swelling is present. These could be signs of a serious condition.

Keep out of the reach of children.

Overdose Warning:

Taking more than the recommended dose can cause serious health problems, including serious liver damage. In case of overdose, get medical help or contact a Poison Control Center immediately. Prompt medical attention is critical, even if you do not notice any signs or symptoms.

Directions

This product does not contain directions or complete warnings for adult use.

  • Give this medicine by mouth only.
  • Only use 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 inner cheek).
  • Do not give more than 5 times 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 62 mL
6 to under 124 mL

Other information
  • Store at 20-25°C (68-77°F)
  • 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.
  • Free of PPA (phenylpropanolamine.)

Inactive ingredients

Citric Acid, Glycerin, High Fructose Corn Syrup, Natural Flavors, PEG, Propylene Glycol, Purified Water, Sodium Benzoate and Sucralose

Questions or comments?

For further information you may contact us at:

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

PRINCIPAL DISPLAY PANEL

Little Colds® by Little Remedies®
MULTI-SYMPTOM COLD FORMULA
Acetaminophen/Dextromethorphan/Phenylephrine
RELIVES STUFFY NOSE, COUGH, FEVER & PAIN
1 FL. OZ. (30 mL)

LITTLE COLDS MULTI SYMPTOM COLD 
acetaminophen and dextromethorphan hydrobromide and phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-404
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN80 mg  in 1.0 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE2.5 mg  in 1.0 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE1.25 mg  in 1.0 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SUCRALOSE 
Packaging
#Item CodePackage Description
1NDC:63029-404-011 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 FINALpart34309/01/2010
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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