Active Ingredients (In Each 5 Ml)
Acetaminophen 160 mg
Chlorpheniramine maleate 1 mg
Dextromethorphan HBr 5 mg
Phenylephrine HCI 2.5 mg
Childrens Plus Flu Suspension
FDA Label NDC 55910-031
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dolgencorp, Inc. (dollar General & Rexall) for the product Childrens Plus Flu (NDC 55910-031). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each 5 ml), purposes, uses, warnings, do not use, ask a doctor before use if your child has, ask a doctor or pharmacist before use if the child is taking, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Pain reliever/fever reducer
Antihistamine
Cough suppressant
Nasal decongestant
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
Warnings
Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
- more than 5 doses in 24 hours, which is the maximum daily amount
- with other drugs contaning acetaminophen
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:
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.
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 |
Other Information
- store at 20-25°C (68-77F) .Do not refrigerate
Inactive Ingredients
carboxymethylcellulose sodium, citric acid, D&C red #33, FD&C red #40, flavors, glycerin, microcrystalline cellulose, purified water, sodium benzoate, sorbitol, sucrose xanthan gum
Questions Or Comments?
Call 1-888-309-9030
Principal Display Panel
For ages 6 to 11 years
Children's
Plus Flu
Acetaminophen / Pain reliever
Chlorpheniramine maleate
Dextromethorphan HBr
Phenylephrine HCI
Oral Suspension
Pain reliever/fever reducer
Antihistamine
Cough suppressant
Nasal decongestant
Relieves coughs, runny nose, sneezing, fever, sore throat, stuffy nose
Grape Flavor
FL OZ (mL)
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY OLD EAST MAIN CO.
100 MISSION RIDGE,
GOODLETTSVILLE, TN 37072
Package Label
DOLLAR GENERAL HEALTH Children's Plus Flu
* Please review the disclaimer below.
