Label: ROMPE PECHO NIGHTTIME- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl liquid
- NDC Code(s): 58593-830-06
- Packager: EFFICIENT LABORATORIES INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 13, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Warnings
Liver warning: This product contains acetaminophen. Sever liver damage may occur if you take
- more than 6 doses in 24 hours, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
Allergy alert: Acetaminophen may cause sever skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is sever, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminphen, 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 a MAOI, ask a doctor or pharmalacist before taking this product.
- to make a child sleep
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
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When using this product
- do not use more than directed
- excitability may occur, especially in children
- marked draowsiness may occur
- 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
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, 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.
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
OVERDOSAGE
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.
-
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 = milliliter
- TBSP = tablespoonful
- this adult product is not intended for use in children under 12 years of age.
age dose Adults and Children 12 years and over 30 mL every 4 hours Children under 12 years of age do not use -
INACTIVE INGREDIENT
Inactive ingredients: blue cohosh root extract, echinacea root extract, eucalyptus oil, flavor, ginkgo bilboa leaf extract, glycerin, goldenseal root extract, honey, horehouns (flower, leaf, stern) extract, licorice root extract, menthol, methylparaben, mullein leaf extract, myrrh gum, potassium citrate, potassium sorbate, propylene glycol, prolylparaben, slippery elm bark extract, sodium chloride, sucralose, water, wild cherry bark extract, zinc sulfate.
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ROMPE PECHO NIGHTTIME
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58593-830 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 PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 30 mL Inactive Ingredients Ingredient Name Strength MYRRH (UNII: JC71GJ1F3L) POTASSIUM CITRATE (UNII: EE90ONI6FF) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) ULMUS RUBRA BARK (UNII: 91QY4PXU8Q) MULLEIN LEAF (UNII: 9936O846LI) SODIUM CHLORIDE (UNII: 451W47IQ8X) SUCRALOSE (UNII: 96K6UQ3ZD4) WATER (UNII: 059QF0KO0R) PRUNUS SEROTINA BARK (UNII: 5D48E975HA) ZINC SULFATE (UNII: 89DS0H96TB) METHYLPARABEN (UNII: A2I8C7HI9T) CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH) 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58593-830-06 1 in 1 CARTON 09/01/2019 1 180 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 09/01/2019 Labeler - EFFICIENT LABORATORIES INC (969044932) Registrant - EFFICIENT LABORATORIES INC (969044932)