Label: DRKIDS CHILDREN MULTI SYMPTOM COLD AND FLU- acetaminophen 320mg, chlorpheniramine maleate 2mg, dextromethorphan hbr 10mg, phenylephrine hcl 5mg solution
- NDC Code(s): 73282-0113-6
- Packager: Calmco
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 18, 2023
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- Active Ingredient (in each 10mL)
- Uses
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Warnings
Liver Warning: this product contains acetaminophen. Severe liver damage may occur if your child takes
■ more than 5 doses in 24 hours, which is the maximum daily amount for this product
■ 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
■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
■ 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.
■ if your child has is allergic to any of the ingredients in this product
Ask a doctor befre use if your child has
■ liver disease ■ high blood pressure ■ heart disease ■ diabetes ■ thyroid disease ■ glaucoma ■ a breathing problem such as chronic bronchitis ■ persistent or chronic cough such as occurs with asthma ■ cough that occurs with too much phlegm (mucus)
Ask a cotor or pharmacist before use if your child is
■ taking the blood thinning drug warfarin ■ taking sedatives or tranquilizers
When using this product
■ do not exceed recommended dosage (see overdose warning)
■ excitability may occur, especially in children
■ marked drowsiness may occur
■ sedatives and tranquilizers may increase the drowsiness effect
Stop use and ask a doctor if
■ 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 ■ redness or swelling is present ■ new symptoms occur ■ cough comes back or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.
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Directions
■ this product does not contain directions or complete warning for adult use
■ do not give more than directed (see overdose warning)
■ find right dosage on chart below
■ empty each Single-Use Vial of all liquid when dosing, following the instructions under "Easy to use" on the side panel
■ repeat dose every 4 hours while symptoms last
■ do not give more than 5 times in 24 hours
■ children under the age of 6, do not use
Dosing Chart
Age (Years) Dose (mL) 6 - 11 years 1 Single use vial (10mL) every 4 hours. Do not give more than 5 times in 24 hours - Inactive ingredients
- Other information
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- Package
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INGREDIENTS AND APPEARANCE
DRKIDS CHILDREN MULTI SYMPTOM COLD AND FLU
acetaminophen 320mg, chlorpheniramine maleate 2mg, dextromethorphan hbr 10mg, phenylephrine hcl 5mg solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73282-0113 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 320 mg in 10 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 5 mg in 10 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 10 mL CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg in 10 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) MALTITOL (UNII: D65DG142WK) EDETATE DISODIUM (UNII: 7FLD91C86K) SORBITOL SOLUTION (UNII: 8KW3E207O2) SODIUM METABISULFITE (UNII: 4VON5FNS3C) WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color Score Shape Size Flavor BERRY (MIXED BERRY FLAVOR) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73282-0113-6 16 in 1 CARTON 02/15/2024 1 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 02/15/2024 Labeler - Calmco (079308308)
