Sanatos Daytime Cb Powder (as)

SPL v9

SPL

SPL Set ID 14484bf5-ff45-b859-e063-6394a90a9a0f

Route

ORAL

Published

Effective Date 2024-03-31

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (650 mg) Dextromethorphan (20 mg) Phenylephrine (10 mg)

Inactive Ingredients

Isopropyl Alcohol Acesulfame Potassium Aspartame Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 40 Maltodextrin Silicon Dioxide Sodium Citrate Sucrose Tribasic Calcium Phosphate Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-03-31

Description

Drug Facts

Medication Information

Description

Drug Facts

Uses

Temporarily relieves common cold/flu symptoms:

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

Section 55105-1

Active ingredients (in each packet)	Purposes
Acetaminophen 650 mg	Pain reliever/ fever reducer
Dextromethorphan HBr 20 mg	Cough suppressant
Phenylephrine HCI 10 mg	Nasal decongestant

Warnings

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

more than 6 packets in 24 hours, which is the maximum daily amount
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

dissolve one packet in an 8 fl oz glass of hot water. If using a microwave; add content into a glass of cool water and stir briskly before and after heating. Do not overheat.
Sip while hot and consume the entire drink within 10-15 minutes
a dults and children 12 years of age and older: one (1) packet every 4 hours, do not exceed 6 packets per 24 hours
children under 12 years of age: 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.

Drug Facts

Drug Facts

Questions?

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

Distributed By:

PHARMADEL LLC

New Castle, DE 19270

Made in India

Other Information

each packet contains: potassium 10 mg, sodium 27 mg
phenylketonurics: contains phenylalanine 13 mg per packet
store at room temperature 68-77°F (20-25°C)
do not use if packets are punctured or torn.

Inactive Ingredients

acesulfame potassium, anhydrous citric acid, aspartame, chamomile berry flavors, FD&C blue 1, FD&C red 40, isopropyl alcohol, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate, water

Principal Display Panel

When Using This Product

do not exceed recommended dosage

Stop Use and Ask A Doctor If

nervousness, dizziness, or sleeplessness occur
redness or swelling is present
pain or nasal congestion gets worse or lasts more than 7 days
fever gets worse or lasts more than 3 days
any new symptoms occur

If Pregnant Or Breast Feeding,

ask a health care professional before use.

Kepp Out of Reach of Children.

In case of accidental 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
a cough that is accompanied by excessive phlegm (mucus)
a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema
difficulty urinating due to enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warafin

Structured Label Content

Uses

Temporarily relieves common cold/flu symptoms:

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

Section 55105-1 (55105-1)

Active ingredients (in each packet)	Purposes
Acetaminophen 650 mg	Pain reliever/ fever reducer
Dextromethorphan HBr 20 mg	Cough suppressant
Phenylephrine HCI 10 mg	Nasal decongestant

Warnings

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

more than 6 packets in 24 hours, which is the maximum daily amount
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

dissolve one packet in an 8 fl oz glass of hot water. If using a microwave; add content into a glass of cool water and stir briskly before and after heating. Do not overheat.
Sip while hot and consume the entire drink within 10-15 minutes
a dults and children 12 years of age and older: one (1) packet every 4 hours, do not exceed 6 packets per 24 hours
children under 12 years of age: do not use

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.

Drug Facts

Drug Facts

Questions?

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

Distributed By: (Distributed by:)

PHARMADEL LLC

New Castle, DE 19270

Made in India

Other Information (Other information)

each packet contains: potassium 10 mg, sodium 27 mg
phenylketonurics: contains phenylalanine 13 mg per packet
store at room temperature 68-77°F (20-25°C)
do not use if packets are punctured or torn.

Inactive Ingredients (Inactive ingredients)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

When Using This Product (When using this product)

do not exceed recommended dosage

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 or nasal congestion gets worse or lasts more than 7 days
fever gets worse or lasts more than 3 days
any new symptoms occur

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health care professional before use.

Kepp Out of Reach of Children. (Kepp out of reach of children.)

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
a cough that is accompanied by excessive phlegm (mucus)
a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema
difficulty 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 the blood thinning drug warafin

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "Temporarily relieves common cold/flu symptoms: minor aches & pains sore throat headache nasal congestion cough due to minor throat & bronchial irritation and temporarily reduces fever", "55105-1": "Active ingredients (in each packet) Purposes Acetaminophen 650 mg Pain reliever/ fever reducer Dextromethorphan HBr 20 mg Cough suppressant Phenylephrine HCI 10 mg Nasal decongestant", "Warnings": "Liver warning: This product contains acetaminophen . Severe liver damage may occur if you take more than 6 packets in 24 hours, which is the maximum daily amount 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": "dissolve one packet in an 8 fl oz glass of hot water. If using a microwave; add content into a glass of cool water and stir briskly before and after heating. Do not overheat. Sip while hot and consume the entire drink within 10-15 minutes a dults and children 12 years of age and older: one (1) packet every 4 hours, do not exceed 6 packets per 24 hours children under 12 years of age: 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.", "Drug Facts": "Drug Facts", "Questions?": "+1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com", "Distributed by:": "PHARMADEL LLC New Castle, DE 19270 Made in India", "Other information": "each packet contains: potassium 10 mg, sodium 27 mg phenylketonurics: contains phenylalanine 13 mg per packet store at room temperature 68-77°F (20-25°C) do not use if packets are punctured or torn.", "Inactive ingredients": "acesulfame potassium, anhydrous citric acid, aspartame, chamomile berry flavors, FD&C blue 1, FD&C red 40, isopropyl alcohol, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate, water", "When using this product": "do not exceed recommended dosage", "Stop use and ask a doctor if": "nervousness, dizziness, or sleeplessness occur redness or swelling is present pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days any new symptoms occur", "If pregnant or breast-feeding,": "ask a health care professional before use.", "Kepp out of reach of children.": "In case of accidental 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 a cough that is accompanied by excessive phlegm (mucus) a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema difficulty urinating due to enlarged prostate gland", "Ask a doctor or pharmacist before use if you are": "taking the blood thinning drug warafin"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:13.688602 · Updated: 2026-03-14T23:12:24.385926