FDA Label for Rompe Pecho Nt NT

Otc - 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

Otc - Purpose

Purpose

Pain reliever/fever reducer

Cough Suppressant

Antihistamine

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.

Otc - 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_

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding,ask a health professional before use.

Otc - 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.

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

Uses

• temporarily relieves these common cold/flu symptoms:
• minor aches and pains• headache• sore throat• runny nose and sneezing • cough • relieves cough to help you get to sleep
• temporarily reduces fever.

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.

Otc - Questions

Questions or Comments?

305-805-3456 Monday - Friday 9AM to 5PM EST

www.efficientlabs.com

Distributed by

Efficient Laboratories, Inc., Miami, Fl 33166

Made in U.S.A.

Ask A Doctor Or Pharmacist Before Use If You Are:

Ask a doctor or pharmacist before use if you are
• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers.

When Using This Product

When using this product • do not use more than directed
• excitability may occur, especially in children• marked drowsiness may occur • avoid alcoholic
drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a
motor vehicle or operating machinery.

Otc - 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.

Otc - 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.

Package Label.Principal Display Panel