Label: ROMPE PECHO NT NT- acetaminophen, dextromethorphan hbr, doxylamine succinate liquid
- NDC Code(s): 58593-003-06
- Packager: Efficient Laboratories Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 8, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active Ingredients:(in each 30ml doses cup) Purpose
Acetaminophen 650mg ............................................................ Pain reliever/fever reducer
Dextromethorphan HBr 20 mg ..................................................Cough Suppressant
Doxylamine succinate 12.5 mg ................................................ Antihistamine
- PURPOSE
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WARNINGS
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur f you take • more than 6 doses in 24 hours, which is the maximum daily amount for this prcx:luct • with other drugs containing acetaminophen • 3 or more alcoholic drinks daily wh le using this product.
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters• rash
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 • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen,ask a doctor or phannacist.
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions,or Parkinson'sdisease),or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a MAOI,ask a doctor or pharmacist before taking this product.
• to make a childsleep_
- PREGNANCY OR BREAST FEEDING
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KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well
as for children even if you do not notice any signs or symptoms.
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DOSAGE & ADMINISTRATION
Directions do not take more than directed (see overdose warning)
- Do not exceed more than 6 doses in any 24-hour period
- Shake well before use
- measure only with dosing cup provided
- keep dosing cup with product
- mL=miliiter TSP=teaspoonful
- this adult product is not intended for use in children under 12 years of age
Age - Dose
- adults and children 12 years of age and over
- 30 mL every 4 hours
- children under 12 years of age
- do not use
- INDICATIONS & USAGE
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INACTIVE INGREDIENT
Inactive ingredients: blue cohosh root extract, citric acid, echinacea root extract, eucalyptus oil, flavor, ginkgo biloba leaf extract, glycerin, goldenseal root extract, honey, horehound (flower, leaf, stem) extract, licorice root extract, menthol, methylparaben, mullein leaf extract, myrrh gum, potassium citrate, potassium sorbate, propylene glycol, Propylparaben, slippery elm bark extract, sodium chloride, sucralose, water, wild cherry bark extract and zinc sulfate.
- QUESTIONS
- Ask a doctor or pharmacist before use if you are:
- When using this product
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ASK DOCTOR
Ask a doctor before use if you have:• liver disease • heart disease • high blood pressure • thyroid disease • diabetes • glaucoma • trouble urinating due to enlarged prostate gland • cough that occurs with too much phlegm (mucus) • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis,or emphysema • a sodium-restricted diet.
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STOP USE
Stop use and ask a doctor if • nervousness, dizziness, or
sleeplessness occur • pain or cough gets worse or lasts more than 7 days • new symptoms occur •fever gets worse or lasts more than 3 days • redness or swelling is present • cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ROMPE PECHO NT NT
acetaminophen, dextromethorphan hbr, doxylamine succinate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58593-003 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg in 30 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 30 mL DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 12.5 mg in 30 mL Inactive Ingredients Ingredient Name Strength POTASSIUM CITRATE ANHYDROUS (UNII: 86R1NVR0HW) CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH) GLYCERIN (UNII: PDC6A3C0OX) ECHINACEA ANGUSTIFOLIA ROOT (UNII: D982V7VT3P) EUCALYPTUS OIL (UNII: 2R04ONI662) GINKGO BILOBA LEAF OIL (UNII: Y5967KO1JH) GOLDENSEAL (UNII: ZW3Z11D0JV) HONEY (UNII: Y9H1V576FH) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) HOREHOUND (UNII: K08036XEJV) MENTHOL (UNII: L7T10EIP3A) METHYLPARABEN (UNII: A2I8C7HI9T) LICORICE (UNII: 61ZBX54883) MULLEIN LEAF (UNII: 9936O846LI) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) ULMUS RUBRA BARK (UNII: 91QY4PXU8Q) SODIUM CHLORIDE (UNII: 451W47IQ8X) PRUNUS SEROTINA BARK (UNII: 5D48E975HA) ZINC SULFATE (UNII: 89DS0H96TB) MYRRH (UNII: JC71GJ1F3L) SUCRALOSE (UNII: 96K6UQ3ZD4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58593-003-06 180 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 10/01/2023 Labeler - Efficient Laboratories Inc (969044932) Registrant - Efficient Laboratories Inc (969044932)