Label: DRKIDS CHILDRENS MUTI SYMPTOM COLD FLU AND SORE THROAT NIGHTTIME- acetaminophen 325mg, diphenhydraine hcl 12.5mg, phenylephrine hcl 5mg solution
- NDC Code(s): 73282-0114-6
- Packager: Calmco LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 18, 2023
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- Official Label (Printer Friendly)
- Active Ingredients (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 ■ with any other product containing diphenhydramine, even one used on the skin■ if 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.
Ask a doctor before 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 doctor or pharmacist before use if your child is
■ taking the blood thinning drug warfarin ■ taking any other nasal decongestant or stimulant ■ taking any other pain reliever/ fever reducer ■ 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 warnings for adult use
■ do not give more than directed (see Overdose warning)
■ dose as follow or as directed by a doctor.
■ follow the instructions under "Easy to Use" on the side panel
■ empty all liquid in each Single-Use Vial when dosing
■ children 6 - 11 years of age: 1 single-use vial (10mL) every 4 hours while symptoms last; do not give more than 5 doses in any 24 hour period
■ children under 6 years of age: 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. - Other Information
- Inactive Ingredients
- Questions or Comments?
- Package Label
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INGREDIENTS AND APPEARANCE
DRKIDS CHILDRENS MUTI SYMPTOM COLD FLU AND SORE THROAT NIGHTTIME
acetaminophen 325mg, diphenhydraine hcl 12.5mg, phenylephrine hcl 5mg solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73282-0114 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg in 10 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 10 mL ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg in 10 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) SODIUM METABISULFITE (UNII: 4VON5FNS3C) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM BENZOATE (UNII: OJ245FE5EU) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) SORBITOL SOLUTION 70% (UNII: 8KW3E207O2) MALTITOL (UNII: D65DG142WK) WATER (UNII: 059QF0KO0R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73282-0114-6 16 in 1 CARTON 02/06/2024 1 10 mL in 1 VIAL, PLASTIC; 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 02/06/2024 Labeler - Calmco LLC (079308308)
