Active ingredient A list of the active, medicinal ingredients in the drug product.
Active ingredients (in each 5 mL) Acetaminophen 325 mg Chlorpheniramine maleate 2 mg Dextromethorphan HBr 6.5 mg Phenylephrine HCl 5 mg
Dosage and administration Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions this product does not contain directions or complete warnings for adult use do not give more than directed use enclosed dosing cup keep dosing cup for use with this product mL = milliliter children under 6 years of age Do not use children 6 to under 12 years of age 5 mL every 4-6 hours, not to exceed 5 doses in 24 hours children 12 years and over 10 mL every 4-6 hours, not to exceed 6 doses in 24 hours
|children under 6 years of age||Do not use|
|children 6 to under 12 years of age||5 mL every 4-6 hours, not to exceed 5 doses in 24 hours|
|children 12 years and over||10 mL every 4-6 hours, not to exceed 6 doses in 24 hours|
Inactive ingredient A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Citric acid, disodium EDTA, flavor, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water and sucralose
Indications and usage A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses temporarily relieves: minor aches and pains headache minor sore throat pain runny nose itchy nose or throat sneezing itchy watery eyes due to hay fever nasal and sinus congestion cough due to minor throat and bronchial irritation as may occur with a cold temporarily reduces fever
Purpose Information about the drug product’s indications for use.
Purposes Pain reliever/fever reducer Antihistamine Cough Suppressant Nasal decongestant
Spl product data elements Usually a list of ingredients in a drug product.
Giltuss Childrens MultiSymptom Cold and Flu Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride POLYETHYLENE GLYCOL, UNSPECIFIED ANHYDROUS CITRIC ACID PROPYLPARABEN GLYCERIN PROPYLENE GLYCOL WATER SUCRALOSE EDETATE DISODIUM EDETIC ACID METHYLPARABEN CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ACETAMINOPHEN ACETAMINOPHEN Light yellow
Package label principal display panel The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Children's Giltuss® MULTI-SYMPTOM COLD & FLU ANALGESIC, ANTITUSSIVE, ANTIHISTAMINE & NASAL DECONGESTANT Alcohol Free. Sodium Free. Sugar Free. Dye Free FEVER, HEADACHE AND BODY ACHES COUGH AND COLD STUFFY NOSE SNEEZING AND RUNNY NOSE STRAWBERRY FLAVOR 4FL OZ (118 mL) 58552-137 Child Multisymptom
Spl unclassified section Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Tamper evident: do not use if safety seal is broken or missing MANUFACTURED FOR GIL PHARMACEUTICAL CORP. PONCE, PUERTO RICO 00717-1565
Ask doctor Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Ask a doctor or pharmacist before use if the child has liver disease heart disease high blood pressure thyroid disease diabetes glaucoma a breathing problem such as chronic bronchitis cough that occurs with too much phlegm (mucus) chronic cough that lasts such as occurs with asthma
Ask doctor or pharmacist Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.
Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin taking sedatives or tranquilizers
Do not use Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use in a child under 4 years of age if your child is allergic to acetaminophen or any inactive ingredient in this product 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. to make your child sleepy
Keep out of reach of children Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Other safety information Information about safe use and handling of the product that may not have been specified in another field.
Other information store at room temperature 15° - 30°C (59° - 86°F) close cap tightly SAVE CARTON FOR COMPLETE DRUG FACTS
Questions A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? Call 1-787-848-9114, Monday-Friday 9AM - 5PM EST. Call your doctor for medical advice in the event of side effects.
Stop use Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if nervousness, dizzyness or sleeplessness 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 headache that lasts. These could be signs of a serious condition.
When using Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product do not exceed recommended dosage marked drowsiness may occur excitability may occur, especially in children
Pregnancy or breast feeding Pregnancy or Breast feeding
If pregnant or breast-feeding , ask a health professional before use.
Warnings Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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 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.