Sanatos Daytime Ms 6 (apta)

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (10 mg) Phenylephrine (5 mg) Acetaminophen (325 mg)

Inactive Ingredients

Anhydrous Citric Acid Water Food Yellow 3 Free Acid Glycerin Sucrose Propylene Glycol Sodium Benzoate Saccharin

Identifiers & Packaging

Pill Appearance

Color: orange

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2014-12-01 Until 2014-12-01

Medication Information

Description

Active ingredients (in each 15 mL, 1 tablespoon) Purposes Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine HCI 5 mg Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

minor aches & pains
headache
sore throat
fever
nasal congestion
cough due to minor throat and bronchial irritation

Section 55105-1

Active ingredients (in each 15 mL, 1 tablespoon)	Purposes
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant
Phenylephrine HCI 5 mg	Nasal decongestant

Warnings

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

adults take more than 4,000 mg if acetaminophen in 24 hours
child take more than 5 doses in 24 hours
taken with other drugs containing acetaminophen
adult has 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

take only as recommended (see overdose warning)
use a dosage cup or tablespoon (TBSP)
do not exceed 4 doses per 24 hrs

age	dose
adults & children 12 years & over	30 mL (2 TBSP) every 4 hours
children 6 years to under 12 years	15 mL (1 b TBSP) every 4 hours
children 4 years to under 6 years	ask a doctor
children under 4 years	do not use

when using daytime and nighttime products, carefully read each label to ensure correct dosing.

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?

call 1-866-359-3478

Distributed By:

Pharmadel LLC

Seaford, DE 19973

www.sanatos.com

Other Information

sodium content per tablespoon: 10 mg
store at room temperature

TAMPER EVIDENT: Do not use if imprinted 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, FD&C yellow #6, flavor, glycerin, propylene glycol, purfied water, saccarhin sodium, sodium benzoate, sucrose

Principal Display Panel

When Using This Product

do not use more than directed (see overdose warning)
avoid alcoholic drinks

Stop Use and Ask A Doctor If

you get nervos, dizzy or sleepless
new symptoms occur
fever gets worse or lasts more than 3 days
pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
redness or swelling is present
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.

Ask A Doctor Before Use If You Have

liver disease
heart disease
thyroid disease
diabetes
high blood pressure
trouble urinating due to enlarged prostate gland
persistent or chronic cough such as occurs with smoking, asthma, or emphysema
cough that occurs with too much phlegm (mucus)

Structured Label Content

Uses

temporarily relieves common cold/flu symptoms:

minor aches & pains
headache
sore throat
fever
nasal congestion
cough due to minor throat and bronchial irritation

Section 55105-1 (55105-1)

Active ingredients (in each 15 mL, 1 tablespoon)	Purposes
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant
Phenylephrine HCI 5 mg	Nasal decongestant

Warnings

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

adults take more than 4,000 mg if acetaminophen in 24 hours
child take more than 5 doses in 24 hours
taken with other drugs containing acetaminophen
adult has 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

take only as recommended (see overdose warning)
use a dosage cup or tablespoon (TBSP)
do not exceed 4 doses per 24 hrs

age	dose
adults & children 12 years & over	30 mL (2 TBSP) every 4 hours
children 6 years to under 12 years	15 mL (1 b TBSP) every 4 hours
children 4 years to under 6 years	ask a doctor
children under 4 years	do not use

when using daytime and nighttime products, carefully read each label to ensure correct dosing.

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?

call 1-866-359-3478

Distributed By: (Distributed by:)

Pharmadel LLC

Seaford, DE 19973

www.sanatos.com

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.

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, FD&C yellow #6, flavor, glycerin, propylene glycol, purfied water, saccarhin sodium, sodium benzoate, sucrose

Principal Display Panel

When Using This Product (When using this product)

do not use more than directed (see overdose warning)
avoid alcoholic drinks

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

you get nervos, dizzy or sleepless
new symptoms occur
fever gets worse or lasts more than 3 days
pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
redness or swelling is present
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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver disease
heart disease
thyroid disease
diabetes
high blood pressure
trouble urinating due to enlarged prostate gland
persistent or chronic cough such as occurs with smoking, asthma, or emphysema
cough that occurs with too much phlegm (mucus)

Advanced Ingredient Data

[{"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "15", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "15", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "FOOD YELLOW 3 FREE ACID", "unii": "G2B7JWK1GG", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCROSE", "unii": "C151H8M554", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "325", "strengthDenominator": "15", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN", "unii": "FST467XS7D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves common cold/flu symptoms: minor aches & pains headache sore throat fever nasal congestion cough due to minor throat and bronchial irritation", "55105-1": "Active ingredients (in each 15 mL, 1 tablespoon) Purposes Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine HCI 5 mg Nasal decongestant", "Warnings": "Liver warning: This product contains acetaminophen. Severe liver damage may occur if adults take more than 4,000 mg if acetaminophen in 24 hours child take more than 5 doses in 24 hours taken with other drugs containing acetaminophen adult has 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": "take only as recommended (see overdose warning) use a dosage cup or tablespoon (TBSP) do not exceed 4 doses per 24 hrs age dose adults & children 12 years & over 30 mL (2 TBSP) every 4 hours children 6 years to under 12 years 15 mL (1 b TBSP) every 4 hours children 4 years to under 6 years ask a doctor children under 4 years do not use when using daytime and nighttime products, carefully read each label to ensure correct dosing.", "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?": "call 1-866-359-3478", "Distributed by:": "Pharmadel LLC Seaford, DE 19973 www.sanatos.com", "Other information": "sodium content per tablespoon: 10 mg store at room temperature TAMPER EVIDENT: Do not use if imprinted 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, FD&C yellow #6, flavor, glycerin, propylene glycol, purfied water, saccarhin sodium, sodium benzoate, sucrose", "When using this product": "do not use more than directed (see overdose warning) avoid alcoholic drinks", "Stop use and ask a doctor if": "you get nervos, dizzy or sleepless new symptoms occur fever gets worse or lasts more than 3 days pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults) redness or swelling is present 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.", "Ask a doctor before use if you have": "liver disease heart disease thyroid disease diabetes high blood pressure trouble urinating due to enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus)"}