FDA Label for Pediacare Multi Symptom Cold
View Indications, Usage & Precautions
Pediacare Multi Symptom Cold Product Label
The following document was submitted to the FDA by the labeler of this product Strides Pharma Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients
(in each 5 mL)
Acetaminophen 160 mg
Chlorpheniramine maleate 1 mg
Dextromethorphan HBr 5 mg
Phenylephrine HCl 2.5 mg
Purposes
Acetaminophen 160 mg………….. Fever reducer/ pain reliever
Chlorpheniramine maleate 1 mg….Antihistamine
Dextromethorphan HBr 5 mg……Cough Suppressant
Phenylephrine HCl 2.5 mg……… Nasal decongestant
Uses
- temporarily relieves these common cold and flu symptoms:
- minor aches and pains
- headache
- sore throat
- stuffy nose
- cough
- sneezing and runny nose
- temporarily reduces fever
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
- skin reddening
- blisters
- rash
- to make a child sleepy
- in 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 do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if the child is allergic to any of the ingredients in this product
- glaucoma
- thyroid disease
- diabetes
- high blood pressure
- heart disease
- a breathing problem such as chronic bronchitis
- persistent or chronic cough such as occurs with asthma
- cough that occurs with excessive phlegm (mucus)
- liver disease
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
- do not exceed recommended dosage (see overdose warning)
- may cause excitability, especially in children
- marked drowsiness may occur
- sedatives and tranquilizers may increase drowsiness
- nervousness, dizziness or sleeplessness occur
- pain, nasal congestion or cough gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
- cough comes back or occurs with rash or headache that lasts.These could be signs of a serious condition.
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
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
Ask a doctor before use if the child has
Ask a doctor or pharmacist before use if child is
When using this product
Stop use and ask a doctor if
Keep Out Of Reach Of Children
Overdose Warning: Taking more than the recommended dose (overdose) could cause serious health problems, including liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.
Directions
- do not take more than directed (see overdose warning)
- do not use in infants
- this product does not contain directions or complete warnings for adult use
- shake well before using
- use only the provided dosing cup
- find right dose on chart below. If possible, use weight to dose; otherwise, use age
- if needed, repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
- mL = millilitre
| Weight (lbs) | Age (yrs) | Dose (mL) |
| under 36 | under 4 | do not use |
| 36 - 47 | 4 to under 6 | do not use unless directed by doctor |
| 48 - 95 | 6 - 11 | 10 mL |
Other Information
- dosage cup provided
- store at 20°-25°C (68°-77°F)
- Tamper Evident: Do not use if printed safety seal on the bottle is broken or missing
Inactive Ingredients
carboxymethylcellulose sodium, citric acid (anhydrous), FD&C blue no.1, FD&C red no.40, flavors, glycerin, microcrystalline cellulose, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum
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PediaCare Multi Symptom Cold
Plus Acetaminophen
Grape Flavor
4 FL OZ (118 mL)
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