Giltuss Multisymptom Cold And Flu Solution
FDA Label NDC 58552-136

Drug Facts

Tamper evident: do not use if safety seal is broken or missing

MANUFACTURED FOR

GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565

Active ingredients (in each 10 mL)

Acetaminophen 650 mg

Chlorpheniramine maleate 4 mg

Dextromethorphan hydrobromide 13 mg

Phenylephrine hydrochloride 10 mg

Purposes

Pain reliever/fever reducer

Antihistamine

Cough Suppressant

Nasal decongestant

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

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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash
• hives
• facial swelling
• asthma (wheezing)
• shock

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.

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.

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

Ask a doctor or pharmacist before use if the user is

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

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

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.

If pregnant or breast-feeding, ask a health professional before use.

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.

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 information

• store at room temperature 15° - 30°C (59° - 86°F)
• close cap tightly
• SAVE CARTON FOR COMPLETE DRUG FACTS

Inactive ingredients citric acid, disodium EDTA, flavor, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water and sucralose

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.

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)



58552-136 (58552 136)