Giltuss Children's Multi-Symptom Cold & Flu
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each 5 mL)
Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Dextromethorphan HBr 6.5 mg
Phenylephrine HCl 5 mg
OTC - PURPOSE SECTION
Purposes
Pain reliever/fever reducer
Antihistamine
Cough Suppressant
Nasal decongestant
INDICATIONS & USAGE SECTION
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 SECTION
Warnings
Liver warning:This product contains acetaminophen. Severe liver damage may occur if your child takes:
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.
- more than 5 doses in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
OTC - DO NOT USE SECTION
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 SECTION
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 SECTION
Ask a doctor or pharmacist before use if the child is
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
OTC - WHEN USING SECTION
When using this product
- do not exceed recommended dosage
- marked drowsiness may occur
- excitability may occur, especially in children
OTC - STOP USE SECTION
Stop use and ask a doctor if
These could be signs of a serious condition.
- 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.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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 SECTION
Directions
| 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 |
- 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
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 SECTION
Inactive ingredients
Citric acid, disodium EDTA, flavor, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water and sucralose
OTC - QUESTIONS SECTION
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.
SPL UNCLASSIFIED SECTION
Tamper evident: do not use if safety seal is broken or missing
MANUFACTURED FOR
GIL PHARMACEUTICAL CORP.
PONCE, PUERTO RICO 00717-1565
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
STRAWBERRY FLAVOR
4FL OZ (118 mL)
- FEVER, HEADACHE AND BODY ACHES
- COUGH AND COLD
- STUFFY NOSE
- SNEEZING AND RUNNY NOSE