Label: GILTUSS MULTISYMPTOM COLD AND FLU- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride solution
- NDC Code(s): 58552-136-04
- Packager: Giltuss Pharmaceutical Corp
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 24, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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
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.
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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.
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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
- ASK DOCTOR/PHARMACIST
- WHEN USING
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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.
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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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
- INACTIVE INGREDIENT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
-
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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INGREDIENTS AND APPEARANCE
GILTUSS MULTISYMPTOM COLD AND FLU
acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58552-136 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 4 mg in 10 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 10 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 13 mg in 10 mL ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg in 10 mL Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) PROPYLPARABEN (UNII: Z8IX2SC1OH) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SUCRALOSE (UNII: 96K6UQ3ZD4) EDETATE DISODIUM (UNII: 7FLD91C86K) METHYLPARABEN (UNII: A2I8C7HI9T) Product Characteristics Color yellow (Light yellow) Score Shape Size Flavor STRAWBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58552-136-04 1 in 1 CARTON 10/02/2018 1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 10/02/2018 Labeler - Giltuss Pharmaceutical Corp (176826592) Establishment Name Address ID/FEI Business Operations Dextrum Laboratories Inc 007392322 manufacture(58552-136)