Childrens Plus Flu

ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI ORAL HUMAN OTC DRUG

Childrens Plus Flu is an FDA drug label for the active ingredient ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI manufactured by Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231206.

Generic name
ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI
Manufacturer
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
55910-031
Application
M012
Label effective
20231206

Active ingredients

Active ingredients (in each 5 mL) Acetaminophen 160 mg Chlorpheniramine maleate 1 mg Dextromethorphan HBr 5 mg Phenylephrine HCI 2.5 mg

Indications & Usage

Uses temporarily relieves the following cold/flu symptoms: minor aches and pains sore throat cough sneezing and runny nose headache stuffy nose temporarily reduces fever

Dosage & Administration

Directions this product does not contain directions or complete warnings for adult use. mL =milliliter shake well before using measure only with dosing cup provided do not use with any other dosing device keep dosing cup with product do not give more than 5 times in 24 hours if needed, repeat dose every 4 hours while symptoms last find the right dose on chart below. If possible, use weight to dose: otherwise us Weight (lb) Age (yr) Dose ( mL) 48-95 6-11 10 mL 36-47 4-5 do not use unless directed by a doctor under 36 under 4 do not use

Contraindications

Not available.

Warnings

Warnings 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. 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 with other drugs contaning 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. Do not use to make a child sleepy with any other drug containing acetaminophen (Prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 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 is allergic to acetaminophen or any of the inactive ingredients in this product. Ask a doctor before use if your child has liver disease glaucoma thyroid disease diabetes heart disease high blood pressure a breathing problem such as chronic bronchitis cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers the blood thinning drug warfarin When using this product do not exceed recommended dose ( see overdose warning ) excitability may occur, especially in children marked drowsiness may occur sedatives and tranquilizers may increase drowsiness Stop use and ask a doctor if new symptoms occur redness or swelling is present pain, nasal congestion or cough gets worse or last more than 5 days fever gets worse or last more than 3 days nervousness, dizziness or sleeplessness occurs 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 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.

Adverse Reactions

Not available.