Rompe Pecho Nt

Rompe Pecho Nt
SPL v6
SPL
SPL Set ID 06faafaa-50a6-c16e-e063-6294a90a49cb
Route
ORAL
Published
Effective Date 2023-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Dextromethorphan (20 mg) Doxylamine (12.5 mg)
Inactive Ingredients
Potassium Citrate Anhydrous Caulophyllum Thalictroides Root Glycerin Echinacea Angustifolia Root Eucalyptus Oil Ginkgo Biloba Leaf Oil Goldenseal Honey Anhydrous Citric Acid Horehound Menthol Methylparaben Licorice Mullein Leaf Potassium Sorbate Propylene Glycol Propylparaben Water Ulmus Rubra Bark Sodium Chloride Prunus Serotina Bark Zinc Sulfate Myrrh Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-01

Description

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


Medication Information

Warnings and Precautions

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.



Indications and 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.



Dosage and 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

Description

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

Section 50565-1

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.



Section 50566-9



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.



Section 50569-3



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.



Section 50570-1



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_



Section 51727-6



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.



Section 51945-4

Section 53413-1

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.

Section 53414-9

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



Section 55105-1

Purpose

Pain reliever/fever reducer

Cough Suppressant

Antihistamine

Section 55106-9

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

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.



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.




Structured Label Content

Indications and Usage (34067-9)

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.



Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

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.



Section 50565-1 (50565-1)

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.



Section 50566-9 (50566-9)



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.



Section 50569-3 (50569-3)



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.



Section 50570-1 (50570-1)



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_



Section 51727-6 (51727-6)



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.



Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

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.

Section 53414-9 (53414-9)

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



Section 55105-1 (55105-1)

Purpose

Pain reliever/fever reducer

Cough Suppressant

Antihistamine

Section 55106-9 (55106-9)

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

When Using This Product (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.



Ask A Doctor Or Pharmacist Before Use If You Are: (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.




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