Sanatos Ms Nighttime 6 (apta)

Sanatos Ms Nighttime 6 (apta)
SPL v2
SPL
SPL Set ID 0ab188f3-f7f9-d665-e063-6294a90a198a
Route
ORAL
Published
Effective Date 2017-12-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Doxylamine (12.5 mg) Dextromethorphan (30 mg) Acetaminophen (650 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Green No. 3 D&c Yellow No. 10 Saccharin Sodium Benzoate Sodium Citrate Propylene Glycol Sucrose Water Fd&c Yellow No. 6 Glycerin Polyethylene Glycol, Unspecified

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-12-01

Description

Active ingredients (in each 30 mL dose cup) Purposes Acetaminophen 650 mg..... Pain reliever/ fever reducer Dextromethorphan HBr 30 mg..... Cough suppressant Doxylamine succinate 12.5 mg..... Antihistamine


Medication Information

Description

Active ingredients (in each 30 mL dose cup) Purposes Acetaminophen 650 mg..... Pain reliever/ fever reducer Dextromethorphan HBr 30 mg..... Cough suppressant Doxylamine succinate 12.5 mg..... Antihistamine

Uses

temporarily relieves these common cold/flu symptoms:

  • sore throat
  • headache
  • minor aches and pains
  • fever
  • runny nose and sneezing
  • cough due to minor throat and bronchial irritation
Section 55105-1
Active ingredients (in each 30 mL dose cup) Purposes
Acetaminophen 650 mg..... Pain reliever/ fever reducer
Dextromethorphan HBr 30 mg..... Cough suppressant
Doxylamine succinate 12.5 mg..... Antihistamine

Warnings

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday 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
  • take only as recommended - see Overdose warning
  • use dose cup or tablespoon (TBSP)
  • do not exceed 4 doses per 24 hours
age dose
adults & children 12 years & over 30 mL(2TBSP) every 6 hours
children 4 to under 12 years ask a doctor
children under 4 years do not use
  • If taking Nighttime at night and Daytime during the day, limit total to 4 doses per 24 hours.
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.
  • to make a child sleepy
Questions?

call 1-866-359-3478

Distributed By:

Pharmadel LLC

Seaford, DE 19973

www.sanatos.com

Other Informaiton
  • each 30 mL dose cup contains: sodium 45 mg
  • store at room temperature

Tamper Evident: Do not use if imprinted shrink band is missing or broken.

Overdose Warning:

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

Inactive Ingredients

citric acid, D&C yellow#10, FD&C Green# 3, FD&C yellow# 6, flavor, glycerin, polythylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose

Princpal Display Panel

When Using This Product
  • do not use more than directed
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness
Stop Use and Ask A Doctor If
  • redness or swelling is present
  • symptoms do not get better within 7 days or are accompanied by fever
  • fever gets worse or lasts more than 3 days
  • cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts

These could be signs of a serious condition.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Ask A Doctor Before Use If You Have
  • a sodium-restricted diet
  • liver disease
  • glaucoma
  • 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
  • trouble urinating due to enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

Structured Label Content

Uses

temporarily relieves these common cold/flu symptoms:

  • sore throat
  • headache
  • minor aches and pains
  • fever
  • runny nose and sneezing
  • cough due to minor throat and bronchial irritation
Section 55105-1 (55105-1)
Active ingredients (in each 30 mL dose cup) Purposes
Acetaminophen 650 mg..... Pain reliever/ fever reducer
Dextromethorphan HBr 30 mg..... Cough suppressant
Doxylamine succinate 12.5 mg..... Antihistamine

Warnings

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday 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
  • take only as recommended - see Overdose warning
  • use dose cup or tablespoon (TBSP)
  • do not exceed 4 doses per 24 hours
age dose
adults & children 12 years & over 30 mL(2TBSP) every 6 hours
children 4 to under 12 years ask a doctor
children under 4 years do not use
  • If taking Nighttime at night and Daytime during the day, limit total to 4 doses per 24 hours.
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.
  • to make a child sleepy
Questions?

call 1-866-359-3478

Distributed By: (Distributed by:)

Pharmadel LLC

Seaford, DE 19973

www.sanatos.com

Other Informaiton (Other informaiton)
  • each 30 mL dose cup contains: sodium 45 mg
  • store at room temperature

Tamper Evident: Do not use if imprinted shrink band is missing or broken.

Overdose Warning: (Overdose warning:)

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

Inactive Ingredients (Inactive ingredients)

citric acid, D&C yellow#10, FD&C Green# 3, FD&C yellow# 6, flavor, glycerin, polythylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose

Princpal Display Panel

When Using This Product (When using this product)
  • do not use more than directed
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • redness or swelling is present
  • symptoms do not get better within 7 days or are accompanied by fever
  • fever gets worse or lasts more than 3 days
  • cough lasts more than 7 days, comes back, or occurs with fever, 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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a sodium-restricted diet
  • liver disease
  • glaucoma
  • 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
  • trouble urinating due to enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

Advanced Ingredient Data


Raw Label Data

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