PediaCare Childrens Plus Cough and Sore Throat
Dosage form: liquid
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 5mg in 5mL, ACETAMINOPHEN 160mg in 5mL
Labeler: Blacksmith Brands, Inc.
NDC Code: 52183-355
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.
Drug Facts
(in each 5 mL, 1 teaspoon)
Acetaminophen 160 mg
Pain reliever/fever reducer
(in each 5 mL, 1 teaspoon)
Dextromethorphan HBr 5 mg
Cough Suppressant
- temporarily relieves the following cold/flu symptoms:
- minor aches and pains
- cough
- headache
- sore throat
- temporarily reduces fever
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
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.
- to make 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.
- glaucoma
- liver disease
- cough that occurs with too much phlegm (mucus)
- chronic cough such as occurs with asthma
your child is taking
- the blood thinning drug warfarin
- do not exceed recommended dose (see overdose warning)
- new symptoms occur
- fever gets worse or lasts for more than 3 days
- redness or swelling is present
- pain, nasal congestion 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.
Taking more than the recommended dose (overdose) may cause liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Quick medical attention is critical even if you do not notice any signs or symptoms.
-
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
- 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
- tsp = teaspoon, mL = milliliter
| Weight (lb) | Age (yr) | Dose (tsp or mL) |
| under 36 | under 4 | do not use |
| 36-47 | 4-5 | do not use unless directed by a doctor |
| 48-95 | 6-11 | 2 tsps or 10 mL |
- dosage cup provided
- store at room temperature
acesulfame potassium, carboxymethylcellulose sodium, cellulose, citric acid, flavors, glycerin, high fructose corn syrup, purified water, red 33, red 40, sodium benzoate, sorbitol, xanthan gum
call 1-888-474-3099
Distributed by:
Blacksmith Brands Inc.
200 White Plains Road
Tarrytown, NY 10591 USA
© 2010
PediaCare® Children’s Fever Reducer
Pain Reliever Plus Cough & Sore Throat
Luden’s® Cherry Taste!
4 FL OZ (118 mL)
| PEDIACARE CHILDRENS PLUS COUGH AND SORE THROAT
dextromethorphan hydrobromide and acetaminophen liquid |
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| Labeler - Blacksmith Brands, Inc. (021411299) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Aaron Industries | 113044205 | MANUFACTURE | |
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
