FDA Label for Giltuss Childrens Multisymptom Cold And Flu
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Giltuss Childrens Multisymptom Cold And Flu Product Label
The following document was submitted to the FDA by the labeler of this product Giltuss Pharmaceutical Corp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Tamper evident: do not use if safety seal is broken or missing
MANUFACTURED FOR
GIL PHARMACEUTICAL CORP.
PONCE, PUERTO RICO 00717-1565
Otc - Active Ingredient
Active ingredients (in each 5 mL)
Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Dextromethorphan HBr 6.5 mg
Phenylephrine HCl 5 mg
Otc - Purpose
Purposes
Pain reliever/fever reducer
Antihistamine
Cough Suppressant
Nasal decongestant
Indications & Usage
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
Warnings
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
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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.
Otc - Do Not Use
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
Otc - Ask Doctor
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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if the child is
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
Otc - When Using
When using this product
- do not exceed recommended dosage
- marked drowsiness may occur
- excitability may occur, especially in children
Otc - Stop Use
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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.
Dosage & Administration
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 |
Other Safety Information
Other information
- store at room temperature 15° - 30°C (59° - 86°F)
- close cap tightly
- SAVE CARTON FOR COMPLETE DRUG FACTS
Inactive Ingredient
Inactive ingredients
Citric acid, disodium EDTA, flavor, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water and sucralose
Otc - Questions
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.
Package Label.Principal Display Panel
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)
* Please review the disclaimer below.