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Giltuss Multi-Symptom Cold & Flu


SPL UNCLASSIFIED SECTION

Drug Facts


OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each 10 mL)

Acetaminophen 650 mg

Chlorpheniramine maleate 4 mg

Dextromethorphan hydrobromide 13 mg

Phenylephrine hydrochloride 10 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:

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.

  • 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

OTC - DO NOT USE SECTION

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 SECTION

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 SECTION

Ask a doctor or pharmacist before use if the user 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
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

OTC - STOP USE SECTION

Stop use and ask a doctor if

These could be signs of a serious condition.

  • 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.

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. Quick 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

adults and children 12 years and over10 mL every 4-6 hours, not to exceed 6 doses in 2 hours
children 6 to under 12 years of age5 mL every 4-6 hours, not to exceed 5 doses in 24 hours
children under 6 years of ageDo not 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 ingredientscitric 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

MAXIMUM STRENGTH

Giltuss® MULTI-SYMPTOM

COLD & FLU

ANALGESIC, ANTITUSSIVE, ANTIHISTAMINE & NASAL DECONGESTANT

ALCOHOL FREE. SODIUM FREE. SUGAR FREE. DYE FREE

RELIEVES

STRAWBERRY FLAVOR

4FL OZ (118 mL)

  • FEVER, HEADACHE AND BODY ACHES
  • COUGH AND COLD
  • SNEEZING
  • RUNNY NOSE
  • ITCHY AND WATERY EYES
  • STUFFY NOSE
  • SINUS PRESSURE