NDC | 58593-828-08 |
Set ID | 938e4e47-d2d9-4b0d-bf88-e9f41b501945 |
Category | HUMAN OTC DRUG LABEL |
Packager | EFFICIENT LABORATORIES INC |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
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ACTIVE INGREDIENT
Active ingredients Purposes
(in each 20mL)
Acetaminophen 650 mg..................................Pain reliever/feverreducer
Dextromethorphan Hbr 20 mg............................Cough suppressant
Guaifenesin 400 mg...........................................Expectorant
Phenylephtine HCl 10 mg...................................Nasal decongestant
- PURPOSE
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INDICATIONS & USAGE
Uses
- temprarily relieves these common cold and flu symptoms:
- nasal congestion
- sinus congestion and pressure
- cough due to minor throat and bronchial irritation
- minor aches and pains
- sore throat
- headache
- temporarily reduces fever
- promotes nasal and/or sinus drainage; temporarily relieves sinus congestion and pressure
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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WARNINGS
Warning
Do not exceed recommended dosage.
- Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlgem(mucus) unless directed by a doctor.
Liver warning: this product contains acetaminophen. Severe liver damage may occur if
- you take more than 6 doses in 24 hours, which is the maximum daily amount for this product
- taken with other drugs containing acetaminophen
- 3 or more alcoholic drinkss every day while using this product
Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headahce, rash, nausea or vomiting, consult a doctor promtly.
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DO NOT USE
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist.
- Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
- 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 pharmamcist before taking this product.
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ASK DOCTOR/PHARMACIST
Ask a doctor before use if you have
- heart disease
- liver disease
- high blood pressure
- thyroid disease
- diabetes
- difficulty in urination due to an enlarged prostate gland
- a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema.
- a cough that is followed by excessive phlegm (mucus)
Ask a docotor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking tranquilizers or sedatives
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STOP USE
Stop use and ask a doctor if
- a symptoms do not improve within 7 days, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition
- nervousness, dizziness or sleeplessness occurs
- pain and nasal congestion gets worse or last more than 5 days (children) or 7 days (adults)
- fever gets worse or last more than 3 days
- redness or swelling is present or new symptoms occur.
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Inactive ingreadients:
Blue cohosh, citirc acid, echinacea, eucalptus oil, ginko biloba, glycerin, golden seal root, honey, horehound herb, licorice root, menthol, methylparaben, mullein leaves, myrrh, potassium citrate, potassium sorbate, propylene glycol, propylparaben, slippery elm bark, sodium chloride, suralose, water, wild cherry bark, zinc sulfate
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ROMPE PECHO MAX MULTI SYMPTOMS
acetaminophen, dextromethophan hbr, phenylephrine hcl, guaifenesin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58593-828 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg in 20 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 20 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg in 20 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 20 mL Inactive Ingredients Ingredient Name Strength CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) EUCALYPTUS OIL (UNII: 2R04ONI662) GINKGO (UNII: 19FUJ2C58T) GLYCERIN (UNII: PDC6A3C0OX) GOLDENSEAL (UNII: ZW3Z11D0JV) HONEY (UNII: Y9H1V576FH) HOREHOUND (UNII: K08036XEJV) LICORICE (UNII: 61ZBX54883) MENTHOL (UNII: L7T10EIP3A) METHYLPARABEN (UNII: A2I8C7HI9T) MULLEIN LEAF (UNII: 9936O846LI) MYRRH (UNII: JC71GJ1F3L) POTASSIUM CITRATE (UNII: EE90ONI6FF) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) ULMUS RUBRA BARK (UNII: 91QY4PXU8Q) SODIUM CHLORIDE (UNII: 451W47IQ8X) SUCRALOSE (UNII: 96K6UQ3ZD4) WATER (UNII: 059QF0KO0R) PRUNUS SEROTINA BARK (UNII: 5D48E975HA) ZINC SULFATE (UNII: 89DS0H96TB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58593-828-08 1 in 1 CARTON 01/01/2014 1 237 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 final part341 01/01/2014 Labeler - EFFICIENT LABORATORIES INC (969044932)