LITTLE COLDS MULTI SYMPTOM COLD PLUS FEVER- acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid
Medtech Products Inc.
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.
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LITTLE REMEDIES MULTI-SYMPTOM COLD plus FEVER
Active ingredients
(in each 5 mL)
Acetaminophen 160 mg
Dextromethorphan HBr 5 mg
Phenylephrine HCI USP 2.5 mg
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. Severe 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
Sore throat warning: If sore throat is severe, persists for more than 2 days, or 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
- if your child is allergic to any of the ingredients in this product
Ask a doctor before use
if the 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
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.
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.
Overdose Warning:
Taking more than the recommended dose (overdose) can cause serious health problems, including serious liver damage In case of overdose, get medical help or contact a Poison Control Center (1-800-222-12221 right away. 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 the enclosed dosing cup. Do not use any other cup, spoon or dosing device when giving this medicine to your child.
- 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.
- mL = milliliters
| Age (yrs) | Dose (mL) |
| under 4 | Do not use |
| 4 to under 6 | 5 mL |
| 6 to under 12 | 10 mL |
Other information
- store at 20°-25°C (68°-77°F)
- Oral dosing device enclosed.
-
Tamper Evident: Do not use if printed shrink band on bottle is broken or missing.
- Check expiration date on bottle or box before using.
- Free of PPA (phenylpropanolamine).
| LITTLE COLDS MULTI SYMPTOM COLD PLUS FEVER
acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid |
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| Labeler - Medtech Products Inc. (122715688) |