PediaCare Childrens Plus Flu description, usages, side effects, indications, overdosage, supplying and lots more!

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PediaCare Childrens Plus Flu

Blacksmith Brands, Inc.

PediaCare Childrens Plus Flu




FULL PRESCRIBING INFORMATION

Drug Facts

(in each 5 mL, 1 teaspoon)

Acetaminophen 160 mg

Pain reliever/fever reducer

(in each 5 mL, 1 teaspoon)

Chlorpheniramine maleate 1 mg

Antihistamine

(in each 5 mL, 1 teaspoon)

Dextromethorphan HBr 5 mg

Cough Suppressant

(in each 5 mL, 1 teaspoon)

Phenylephrine HCI 2.5 mg

Nasal decongestant

  • temporarily relieves the following cold/flu symptoms:
  • minor aches and pains
  • headache
  • sore throat
  • stuffy nose
  • cough
  • sneezing and runny nose
  • 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
  • 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 too much phlegm (mucus)
  • liver disease

your child is taking

  • sedatives or tranquilizers
  • the blood thinning drug warfarin 
  • do not exceed recommended dose (see overdose warning)
  • may cause excitability, especially in children
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • neverousness, dizziness or sleeplessness occur
  • redness or swelling is present
  • pain, nasal congestion or cough gets worse or lasts for more than 5 days
  • fever gets worse or lasts for more than 3 days
  • new symptoms occur
  • 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)
  • 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

carboxymethylcellulose sodium, cellulose, citric acid, flavors, purified water, red 33, red 40, sodium benzoate, sorbitol, sucrose, 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 Flu
BubbleGum Taste!
4 FL OZ (118 mL)

PediaCare Childrens Plus Flu

PediaCare Childrens Plus Flu

Chloropheniramine Maleate and Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride and Ace LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:52183-365
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 5 mg
ACETAMINOPHEN ACETAMINOPHEN 160 mg
Chlorpheniramine Maleate CHLORPHENIRAMINE 1 mg

Inactive Ingredients

Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM
Citric acid
water
D&C RED NO. 33
FD&C RED NO. 40
SODIUM BENZOATE
sorbitol
SUCROSE
XANTHAN GUM

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 113 in 1 BOTTLE
2 NDC:52183-365-04 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2010-07-09


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