FDA Label for Rompe Pecho Nighttime
View Indications, Usage & Precautions
Rompe Pecho Nighttime Product Label
The following document was submitted to the FDA by the labeler of this product Efficient Laboratories Inc. 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.
Otc - Active Ingredient
Active ingredients (in each 30 mL dose cup)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Doxylamine Succinate 12.5 mg
Phenylephrine HCl 10 mg
Otc - Purpose
Purpose
Paint reliever/fever reducer
Cough Suppressant
Antihistamine
Nasal decongestant
Indications & Usage
Uses temporarily relieves these common cold/flu symtoms:
- minor aches and pains
- headache
- nasal congestion
- sore throat
- runny nose and sneezing
- cough
- sinus congestion and pressure
- helps clear nasal passages
- relieves cough to help you get to sleep
- temporarily reduces fever
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
- skin reddening
- blisters
- rash
- 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 you prescription drug contains a MAOI, ask a doctor or pharmalacist before taking this product.
- to make a child sleep
- 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
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
- do not use more than directed
- excitability may occur, especially in children
- marked draowsiness may occur
- acoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- 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.
Allergy alert: Acetaminophen may cause sever skin reactions. Symptoms may include:
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
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
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
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 any other dosing device. Product color & flavor may vary due to natural honey.
- mL = milliliter
- shake well before use
- keep dosing cup with product
- Adults and Children 12 years & 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.
Otc - Questions
Questions or Comments? 305-805-3456
Monday - Friday (9 AM - 5 PM EST) or www.efficientlabs.com
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