FDA Label for Rompe Tos X Adults
View Indications, Usage & Precautions
- OTHER
- PURPOSE
- USES
- LIVER WARNING:
- ALLERGY ALERT:
- SORE THROAT WARNING:
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - 177 ML BOTTLE LABEL
Rompe Tos X Adults Product Label
The following document was submitted to the FDA by the labeler of this product Opmx Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Purpose
Active ingredients (in each 20 mL) | Purpose |
Acetaminophen 500 mg | Pain reliever/fever reducer |
Dextromethorphan HBr 26.66 mg | Cough suppressant |
Guaifenesin 400 mg | Expectorant |
Phenylephrine HCl 10 mg | Nasal descongestant |
Uses
temporarily relieves these common cold/flu symptoms:
- sinus congestion & pressure
- minor aches & pains
- nasal congestion
- cough due to minor throat & bronchial irritation
- sore throat
- headache
- temporarily reduces fever
- temporarily promotes nasal and/or sinus drainage
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Liver Warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
• more than 6 doses in 24 hrs, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 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
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.
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 pharmacist.
- for children under 12 years of age
- 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
- liver disease
- heart disease
- diabetes
- thyroid disease
- high blood pressure
- trouble urinating due to enlarged prostate gland
- persistent or chronic cough sush as smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
Ask A Doctor Or Pharmacist Before Use If You Are
- taking the blood thinning drug warfarin
- taking sodium restricted diet
When Using This Product
- do not exceed recommended dose (see overdose warning)
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
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Overdose Warning
Taking more than recommended dose (overdose) may cause liver damaage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.
Directions
- do not take more than directed (see Overdose warning)
- do not take more than 6 doses in any 24 hour period
- measure only with dosing cup provided
- do not use dosing cup with other products
- dose as follows or as directed by a doctor
- mL = milliliter
- tsp = teaspoonful
Age | Dose |
adults and children 12 years of age and older | 20 mL in dosing cup provided every 4 hours |
Children under 12 years of age | do not use |
Other Information
- each 20 mL contains
- sodium 20 mg
- Store between 20-25°C (68-77°F)
- do not refrigerate
- keep carton for complete Drug facts
Inactive Ingredients
Aloe vera, citric acid, disodium EDTA, FD&C red no. 40, hydroxyethyl cellulose, natural & artificial strawberry flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose
Questions?
Call 616-600-5632 MON to FRI, 9 a.m. to 6 p.m. PTZ
Principal Display Panel - 177 Ml Bottle Label
NDC 69729-785-06
Rompe Tos X
6 fl oz (177 mL)
* Please review the disclaimer below.