Little Colds Multi Symptom Cold description, usages, side effects, indications, overdosage, supplying and lots more!

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Little Colds Multi Symptom Cold

Medtech Products Inc.

Little Colds Multi Symptom Cold Formula




FULL PRESCRIBING INFORMATION

Drug Facts

(in each 1.0 mL)

Acetaminophen 80 mg

Pain reliever/fever reducer

(in each 1.0 mL)

Dextromethorphan HBr 2.5mg

Cough Suppressant

(in each 1.0 mL)

Phenylephrine HCI USP 1.25 mg

Nasal Decongestant

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

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

if your child has liver disease.

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.

  • 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.

  • 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

DO NOT EXCEEED RECOMMENDED DOSAGE.

  • 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.

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.

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 4 do not use
4 to under 6 2 mL
6 to under 12 4 mL
  • 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.)

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

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.

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

Little Colds Multi Symptom Cold

Acetaminophen and Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63029-404
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 80 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 2.5 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 1.25 mg

Inactive Ingredients

Ingredient Name Strength
Citric acid
GLYCERIN
HIGH FRUCTOSE CORN SYRUP
propylene glycol
water
SODIUM BENZOATE
Sucralose

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 BOTTLE, DROPPER
2 NDC:63029-404-01 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2010-09-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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