FDA Label for Giltuss 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 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 10 mL)
Acetaminophen 650 mg
Chlorpheniramine maleate 4 mg
Dextromethorphan hydrobromide 13 mg
Phenylephrine hydrochloride 10 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:
- adult takes more than 6 doses in 24 hours, which is the maximum daily amount
- child takes more than 5 doses in 24 hours
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
- skin reddening
- blisters
- rash
- hives
- facial swelling
- asthma (wheezing)
- shock
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
- if you are 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.
- if you are now 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.
Otc - Ask Doctor
Ask a doctor or pharmacist before use if the user 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 smoking, asthma, or emphysema
- trouble urinating due to enlargement of the prostate gland
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if the user 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
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Otc - Stop Use
Stop use and ask a doctor if
- you get nervousness, dizzyness or sleeplessness
- pain, nasal congestion, or cough gets worse or lasts more than 7 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Dosage & Administration
Directions
- do not give more than directed
- use enclosed dosing cup
- keep dosing cup for use with this product
- mL = milliliter
adults and children 12 years and over | 10 mL every 4-6 hours, not to exceed 6 doses in 2 hours |
children 6 to under 12 years of age | 5 mL every 4-6 hours, not to exceed 5 doses in 24 hours |
children under 6 years of age | Do not use |
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
MAXIMUM STRENGTH
Giltuss® MULTI-SYMPTOM
COLD & FLU
ANALGESIC, ANTITUSSIVE, ANTIHISTAMINE & NASAL DECONGESTANT
ALCOHOL FREE. SODIUM FREE. SUGAR FREE. DYE FREE
RELIEVES
- FEVER, HEADACHE AND BODY ACHES
- COUGH AND COLD
- SNEEZING
- RUNNY NOSE
- ITCHY AND WATERY EYES
- STUFFY NOSE
- SINUS PRESSURE
STRAWBERRY FLAVOR
4FL OZ (118 mL)
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