Sanatos Ms Display 2x50 - Vovantis

Sanatos Ms Display 2x50 - Vovantis
SPL v3
SPL
SPL Set ID df260190-89e7-b338-e053-2995a90a32cb
Route
ORAL
Published
Effective Date 2020-08-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (15 mg) Guaifenesin (200 mg) Phenylephrine (5 mg)
Inactive Ingredients
Water Silicon Dioxide Stearic Acid Povidone K30 Talc Starch, Corn Cellulose, Microcrystalline Crospovidone

Identifiers & Packaging

Pill Appearance
Imprint: A12 Shape: oval Color: white Size: 17 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-08-01

Description

Active ingredients (in each tablet) Purposes Acetaminophen 325 mg Pain reliever/ fever reducer Dextromethorphan HBr 15 mg Cough suppressant Guaifenesin 200 mg Expectorant Phenylephrine HCI 5 mg Nasal decongestant


Medication Information

Description

Active ingredients (in each tablet) Purposes Acetaminophen 325 mg Pain reliever/ fever reducer Dextromethorphan HBr 15 mg Cough suppressant Guaifenesin 200 mg Expectorant Phenylephrine HCI 5 mg Nasal decongestant

Uses

Temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • minor aches and pain
  • headache
  • nasal congestion due to hay fever
  • sore throat
  • sinus congestion
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily reduces fever
Section 55105-1
Active ingredients (in each tablet) Purposes
Acetaminophen 325 mg Pain reliever/ fever reducer
Dextromethorphan HBr 15 mg Cough suppressant
Guaifenesin 200 mg

Expectorant

Phenylephrine HCI 5 mg Nasal decongestant

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 8 tablets in 24 hours, 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.

Directions
  • do not exceed recommended dosage
  • adults and children 12 years of age and older:
  • take 2 tablets every 6-8 hours; do not exceed 8 tablets in a 24-hour period
  • children under 12 years of age: consult a doctor
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.
  • 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.
Other Information
  • store at room temperature 59-86F (15-30C)
  • avoid excessive heat and humidity
  • Do not use if packet is open or torn.
Inactive Ingredients

corn starch, microcrystalline cellulose, crospovidone, povidone k30, silicon dioxide, stearic acid, talc, water

Questions & Comments?

+1-866-359-3478 (M-F) 9AM to 5 PM EST or www.pharmadel.com

Dist. by/ por:

PHARMADEL LLC

New Castle, DE 19720

Made in India/ Hecho en India

Prinicpal Display Panels

Stop Use and Ask A Doctor If
  • nervousness, dizziness, or sleeplessness occur
  • redness or swelling is present
  • pain gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • a persistent cough or symptoms do not improve within 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Ask A Doctor Before Use If You Have
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland
  • a cough that is accompanied by excessive phlegm (mucus)
  • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin

Structured Label Content

Uses

Temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • minor aches and pain
  • headache
  • nasal congestion due to hay fever
  • sore throat
  • sinus congestion
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily reduces fever
Section 55105-1 (55105-1)
Active ingredients (in each tablet) Purposes
Acetaminophen 325 mg Pain reliever/ fever reducer
Dextromethorphan HBr 15 mg Cough suppressant
Guaifenesin 200 mg

Expectorant

Phenylephrine HCI 5 mg Nasal decongestant

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 8 tablets in 24 hours, 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.

Directions
  • do not exceed recommended dosage
  • adults and children 12 years of age and older:
  • take 2 tablets every 6-8 hours; do not exceed 8 tablets in a 24-hour period
  • children under 12 years of age: consult a doctor
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 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 an MAOI, ask a doctor or pharmacist before taking this product.
Other Information (Other information)
  • store at room temperature 59-86F (15-30C)
  • avoid excessive heat and humidity
  • Do not use if packet is open or torn.
Inactive Ingredients (Inactive ingredients)

corn starch, microcrystalline cellulose, crospovidone, povidone k30, silicon dioxide, stearic acid, talc, water

Questions & Comments? (Questions & comments?)

+1-866-359-3478 (M-F) 9AM to 5 PM EST or www.pharmadel.com

Dist. by/ por:

PHARMADEL LLC

New Castle, DE 19720

Made in India/ Hecho en India

Prinicpal Display Panels

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • nervousness, dizziness, or sleeplessness occur
  • redness or swelling is present
  • pain gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • a persistent cough or symptoms do not improve within 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (KEEP OUT OF REACH OF CHILDREN.)

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland
  • a cough that is accompanied by excessive phlegm (mucus)
  • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)