Sanatos Daytime Ms 6 (ple)

Sanatos Daytime Ms 6 (ple)
SPL v1
SPL
SPL Set ID 0a5fc0ef-ba34-bb0b-e063-6394a90af7d9
Route
ORAL
Published
Effective Date 2023-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Acetaminophen (650 mg)
Inactive Ingredients
Anhydrous Citric Acid Water Food Yellow 3 Free Acid Glycerin Propylene Glycol Sodium Benzoate Sucralose Sorbitol Solution Xanthan Gum Menthol

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-01

Description

Active ingredients (in each 30 mL) Purposes Acetaminophen 650 mg Pain reliever/ fever reducer Dextromethorphan HBr 20 mg Cough suppressant


Medication Information

Description

Active ingredients (in each 30 mL) Purposes Acetaminophen 650 mg Pain reliever/ fever reducer Dextromethorphan HBr 20 mg Cough suppressant

Uses

Temporarily relieves common cold/flu symptoms associted with

  • minor aches & pains
  • headache
  • sore throat
  • fever
  • cough due to minor throat and bronchial irritation
Section 55105-1

Active ingredients

(in each 30 mL)

Purposes
Acetaminophen 650 mg Pain reliever/ fever reducer
Dextromethorphan HBr 20 mg Cough suppressant

Warnings

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

  • adults take more than 6 doses in 24 hours, which is the maxium daily amount
  • child takes more than 4 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product

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
  • use only dosing cup provided
  • shake well before use
  • if you are taking other cold/flu products, read complete labeling before dosing
adults & children 12 years & over 30 mL every 4 hours, do not exceed (child) 4 doses and (adult) 6 doses per 24 hours
children under 12 years of age do not use

Do Not Use
  • 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.
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Questions?

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

Distributed By:

Pharmadel LLC

New Castle, DE 19720

www.pharmadel.com

Facebook/PHARMADELUSA

Other Information

  • sodium content per tablespoon: 10 mg
  • store at room temperature

TAMPER EVIDENT: Do not use if imprinted band is missing or broken.

Inactive Ingredients

citric acid anhydrous, FD&C yellow #6, flavor, glycerin, menthol, propylene glycol, sodium benzoate, sorbitol solution, sodium citrate, sucralose, xanthan gum, water

Prinicipal Display Panel

Stop Use and Ask A Doctor If
  • pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
  • 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.

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 User
  • has a sodium restricted diet
  • has liver disease
  • hastrouble urinating due to enlarged prostate gland
  • haspersistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • has a cough that occurs with too much phlegm (mucus)
  • is a child with pain of arthritis



Ask A Doctor Or Pharmacist Before Use If the User Is
  • taking the blood thinning drug warfarin

Structured Label Content

Uses

Temporarily relieves common cold/flu symptoms associted with

  • minor aches & pains
  • headache
  • sore throat
  • fever
  • cough due to minor throat and bronchial irritation
Section 55105-1 (55105-1)

Active ingredients

(in each 30 mL)

Purposes
Acetaminophen 650 mg Pain reliever/ fever reducer
Dextromethorphan HBr 20 mg Cough suppressant

Warnings

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

  • adults take more than 6 doses in 24 hours, which is the maxium daily amount
  • child takes more than 4 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product

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
  • use only dosing cup provided
  • shake well before use
  • if you are taking other cold/flu products, read complete labeling before dosing
adults & children 12 years & over 30 mL every 4 hours, do not exceed (child) 4 doses and (adult) 6 doses per 24 hours
children under 12 years of age do not use

Do Not Use (Do not use)
  • 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.
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Questions?

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

Distributed By: (Distributed by:)

Pharmadel LLC

New Castle, DE 19720

www.pharmadel.com

Facebook/PHARMADELUSA

Other Information (Other information)

  • sodium content per tablespoon: 10 mg
  • store at room temperature

TAMPER EVIDENT: Do not use if imprinted band is missing or broken.

Inactive Ingredients (Inactive ingredients)

citric acid anhydrous, FD&C yellow #6, flavor, glycerin, menthol, propylene glycol, sodium benzoate, sorbitol solution, sodium citrate, sucralose, xanthan gum, water

Prinicipal Display Panel

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
  • 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, (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 User (Ask a doctor before use if user)
  • has a sodium restricted diet
  • has liver disease
  • hastrouble urinating due to enlarged prostate gland
  • haspersistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • has a cough that occurs with too much phlegm (mucus)
  • is a child with pain of arthritis



Ask A Doctor Or Pharmacist Before Use If the User Is (Ask a doctor or pharmacist before use if the user is)
  • taking the blood thinning drug warfarin

Advanced Ingredient Data


Raw Label Data

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