FDA Label for Pediacare-cough-runnynose
View Indications, Usage & Precautions
Pediacare-cough-runnynose 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
Purpose
Acetaminophen 160 mg…………….Fever reducer/Pain reliever
Chlorpheniramine maleate 1 mg……Antihistamine
Dextromethorphan HBr 5 mg………Cough suppressant
Uses
temporarily relieves the following cold/flu symptoms:
- minor aches and pains
- cough
- headache
- sore throat
- sneezing and runny nose
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Sever liver damage may occur if the child takes:
- more than 5 doses in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- skin reddening
- blisters
- rash
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.
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Do Not Use
- 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 non-prescription). 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.
Ask A Doctor Before Use If The Child Has
- glaucoma
- liver disease
- a breathing problem such as chronic bronchitis
- cough that occurs with excessive phlegm (mucus)
- persistent or chronic cough such as occurs with asthma
Ask A Doctor Or Pharmacist Before Use If Child Is Taking
- sedatives or tranquilizers
- the blood thinning drug warfarin
When Using This Product
- do not exceed recommended dosage (see overdose warning)
- may cause excitability, especially in children
- marked drowsiness may occur
- sedatives and tranquilizers may increase drowsiness
Stop Use And Ask A Doctor If
- new symptoms occur
- fever gets worse or lasts for more than 3 days
- redness or swelling is present
- pain or cough gets worse or lasts for more than 5 days
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition
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 exceed recommended dosage (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 dosing cup provided
- 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 = milliliter
- dosage cup provided
- store at room temperature
- Tamper Evident: Do not use if printed safety seal on the bottle is broken or missing.
| Weight (lbs) | Age (yrs) | Dose (mL) |
| under 36 | under 4 | do not use |
| 36 - 47 | 4 - 5 | do not use unless directed by a doctor |
| 48-95 | 6-11 | 10 mL |
Other information
Inactive Ingredients
citric acid, FD&C red no.40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose / carboxymethylcellulose sodium, potassium sorbate, purified water, sorbitol, sucralose, xanthan gum.
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PediaCare® Children Cough & Runny Nose
Fever, Sore Throat & Sneezing
4 FL OZ FL (118 mL)
Cherry Flavor
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