Label: PEDIACARE-COUGH-RUNNYNOSE- acetaminophen,chlorpheniramine maleate,dextromethorphan liquid
- NDC Code(s): 59556-852-58
- Packager: Strides Pharma Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated August 7, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Purpose
- Uses
-
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
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:
- skin reddening
- blisters
- rash
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
- Ask a doctor or pharmacist before use if child is taking
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
- Overdose Warning
-
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
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
- dosage cup provided
- store at room temperature
- Tamper Evident: Do not use if printed safety seal on the bottle is broken or missing.
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PEDIACARE-COUGH-RUNNYNOSE
acetaminophen,chlorpheniramine maleate,dextromethorphan liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59556-852 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 Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color Score Shape Size Flavor CHERRY (Cherry Flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59556-852-58 118 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(59556-852) , ANALYSIS(59556-852) , LABEL(59556-852) , PACK(59556-852)
