PEDIACARE MULTI SYMPTOM COLD- acetaminophen,chlorpheniramine maleate,dextromethorphan hbr,phenylephrine hcl liquid
PediaCare Multi Symptom Cold by
Drug Labeling and Warnings
PediaCare Multi Symptom Cold by is a Otc medication manufactured, distributed, or labeled by Strides Pharma Inc, Fareva Richmond, Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- Drug Facts
- Active ingredients
- Purposes
- Uses
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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
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
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
- 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
Ask a doctor before use if the child has
- 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
Ask a doctor or pharmacist before use if child is
- 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.
-
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.
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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
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PEDIACARE MULTI SYMPTOM COLD
acetaminophen,chlorpheniramine maleate,dextromethorphan hbr,phenylephrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 59556-851 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg in 5 mL CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 1 mg in 5 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 5 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 5 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color Score Shape Size Flavor GRAPE (Grape Flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 59556-851-58 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/09/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/09/2010 Labeler - Strides Pharma Inc (078868278) Establishment Name Address ID/FEI Business Operations Fareva Richmond, Inc. 969523245 MANUFACTURE(59556-851) , ANALYSIS(59556-851) , LABEL(59556-851) , PACK(59556-851)
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