Label: GILTUSS- dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride syrup
- NDC Code(s): 58552-122-01, 58552-122-08
- Packager: Gil Pharmaceutical Corp
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredients
(in each 5 mL teaspoonful)
Dextromethorphan HBr, 28 mg
Guaifenesin, 388 mg
Phenylephrine HCl, 10 mgClose
- temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive
- temporarily relieves nasal congestion due to a cold
Do not use 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 before use if you have
- heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate unless directed by a doctor
- a cough with too much phlegm (mucus)
- a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask a doctor or pharmacist before use if you are
taking sedatives, tranquilizers and drugs used for depression, especially monoamine oxidase inhibitors (MAOIs).
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- cough lasts for more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These can be signs of a serious condition.
Keep out of reach of children.
In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
- do not exceed recommended dosage
- take every 6-8 hours
adults and children 12 years & over 5 mL (1 teaspoonful) children 6 to under 12 years of age 2.5 mL (1/2 teaspoon) children 2 to 6 years of age 1.25 mL (1/4 teaspoon) children under 2 years of age Consult a doctor
- Other information
- Tamper evident: Do not use if safety seal is broken or missing
- Store at controlled room temperature, between 15°-30°C (59°-86°F)
- Inactive ingredients
Artificial grape and vanilla flavor, bitter mask, citric acid, grapeskin extract, menthol, monoammonium glycyrrhizinate, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose. Sodium citrate may be used to adjust pH.Close
- Questions or Comments?
Call 1-877-746-9114, Mon.-Fri. 8:00 am thru 5:00 pm EST. Call your doctor for medical advice in the event of side effects.
Rev. 324:01 6/10Close
- Package/Label Principal Display Panel
NEW IMPROVED FORMULA
Each 5 mL (one teaspoonful) contains:
Dextromethorphan HBr............................28 mg
Phenylephrine HCl..................................10 mgClose
- INGREDIENTS AND APPEARANCE
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride syrup
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:58552-122 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 28 mg in 5 mL GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 388 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 5 mL Inactive Ingredients Ingredient Name Strength WATER POLYETHYLENE GLYCOL 1450 PROPYLENE GLYCOL MENTHOL SORBITOL SUCRALOSE ANHYDROUS CITRIC ACID SODIUM BENZOATE GLYCYRRHIZIN, AMMONIATED ANHYDROUS TRISODIUM CITRATE Product Characteristics Color PURPLE (clear, purple) Score Shape Size Flavor GRAPE (artificial grape flavor and grapeskin extract powder) , VANILLA (artificial vanilla flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58552-122-08 237 mL in 1 BOTTLE 2 NDC:58552-122-01 30 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 10/19/2009 Labeler - Gil Pharmaceutical Corp (176826592) Registrant - Hi-Tech Pharmacal Co., Inc. (101196749) Establishment Name Address ID/FEI Business Operations Hi-Tech Pharmacal Co., Inc. 101196749 MANUFACTURE