Sanatos Daytime Softgels (hhh)

SPL v1

SPL

SPL Set ID 3bddcd5a-7776-49ff-e063-6294a90a5dd1

Route

ORAL

Published

Effective Date 2025-08-08

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

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

Inactive Ingredients

Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Glycerin Polyethylene Glycol 400 Povidone K30 Propylene Glycol Water Sorbitol Sorbitan

Identifiers & Packaging

Pill Appearance

Imprint: CF01 Shape: capsule Color: red Size: 21 mm

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-08-08

Description

Purpose

Medication Information

Purpose

Description

Uses

Temporarily relieves cough-cold symptoms

cough due to minor throat and bronchial irritation
headache
minor aches and pains
nasal congestion
sinus congestion and pressure
stuffy nose
temporarily reduces fever

Section 55105-1

Active ingredients (in each softgel)	Purposes
Acetaminophen 325 mg ....................	Pain reliever/ fever reducer
Dextromethorphan HBr 10 mg .........	Cough suppressant
Phenylephrine HCl 5 mg ..................	Nasal decongestant

Warnings

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

more than 8 softgels in 24 hours, which is the maximum daily
with other drugs containing acetaminophen
3 or more alcoholic drinks daily while using this product

Allergy alert: Acetaminophenmay cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash.

If a skin reaction occurs, stop use and seek medical help right away.

Directions

do not exceed 4 doses in a 24 hour period

Age	Dose
adults and children 12 years and older	2 softgels every 4 hours, do not exceed 6 doses in a 24 hour period
children 4 to under 12 years	consult a doctor
children under 4 years	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

Dist By/ Por:

PHARMADEL LLC

New Castle, DE 19720

www.pharmadel.com

Other Information

store between 68-77°F (20-25°C)
avoid excessive heat
do not use if blister pack unit is punctured or torn

Inactive Ingredients

FD&C red #40, FD&C yellow #6, gelatin, glycerol, polyethylene glycol 400, povidone k30, propylene glycol, sorbitol sorbitan solution, water

Questions Or Comments?

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

Principal Display Panel

When Using This Product

do not exceed recommended dosage

Stop Use and Ask A Doctor If

nervousness, dizziness, or sleeplessness occur
pain, cough or nasal congestions gets worse or lasts more than 7 days
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 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.

Active Ingredients and Purposes

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 or emphysema
difficulty urinating due to enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin

Structured Label Content

Uses

Temporarily relieves cough-cold symptoms

cough due to minor throat and bronchial irritation
headache
minor aches and pains
nasal congestion
sinus congestion and pressure
stuffy nose
temporarily reduces fever

Section 55105-1 (55105-1)

Active ingredients (in each softgel)	Purposes
Acetaminophen 325 mg ....................	Pain reliever/ fever reducer
Dextromethorphan HBr 10 mg .........	Cough suppressant
Phenylephrine HCl 5 mg ..................	Nasal decongestant

Warnings

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

more than 8 softgels in 24 hours, which is the maximum daily
with other drugs containing acetaminophen
3 or more alcoholic drinks daily while using this product

Allergy alert: Acetaminophenmay cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash.

If a skin reaction occurs, stop use and seek medical help right away.

Directions

do not exceed 4 doses in a 24 hour period

Age	Dose
adults and children 12 years and older	2 softgels every 4 hours, do not exceed 6 doses in a 24 hour period
children 4 to under 12 years	consult a doctor
children under 4 years	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

Dist By/ Por: (Dist by/ por:)

PHARMADEL LLC

New Castle, DE 19720

www.pharmadel.com

Other Information (Other information)

store between 68-77°F (20-25°C)
avoid excessive heat
do not use if blister pack unit is punctured or torn

Inactive Ingredients (Inactive ingredients)

FD&C red #40, FD&C yellow #6, gelatin, glycerol, polyethylene glycol 400, povidone k30, propylene glycol, sorbitol sorbitan solution, water

Questions Or Comments? (Questions or comments?)

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

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
pain, cough or nasal congestions gets worse or lasts more than 7 days
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.)

Active Ingredients and Purposes (Active ingredients and Purposes)

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 or emphysema
difficulty urinating due to enlargement of the 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 warfarin

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "Temporarily relieves cough-cold symptoms cough due to minor throat and bronchial irritation headache minor aches and pains nasal congestion sinus congestion and pressure stuffy nose temporarily reduces fever", "55105-1": "Active ingredients (in each softgel) Purposes Acetaminophen 325 mg .................... Pain reliever/ fever reducer Dextromethorphan HBr 10 mg ......... Cough suppressant Phenylephrine HCl 5 mg .................. Nasal decongestant", "Warnings": "Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 softgels in 24 hours , which is the maximum daily with other drugs containing acetaminophen 3 or more alcoholic drinks daily 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.", "Directions": "do not exceed 4 doses in a 24 hour period Age Dose adults and children 12 years and older 2 softgels every 4 hours, do not exceed 6 doses in a 24 hour period children 4 to under 12 years consult a doctor children under 4 years 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": ".", "Dist by/ por:": "PHARMADEL LLC New Castle, DE 19720 www.pharmadel.com", "Other information": "store between 68-77°F (20-25°C) avoid excessive heat do not use if blister pack unit is punctured or torn", "Inactive ingredients": "FD&C red #40, FD&C yellow #6, gelatin, glycerol, polyethylene glycol 400, povidone k30, propylene glycol, sorbitol sorbitan solution, water", "Questions or comments?": "+1-866-359-3478 (M-F) 9 AM - 5 PM EST or www.pharmadel.com", "When using this product": "do not exceed recommended dosage", "Stop use and ask a doctor if": "nervousness, dizziness, or sleeplessness occur pain, cough or nasal congestions gets worse or lasts more than 7 days 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 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.", "Active ingredients and Purposes": ".", "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 or emphysema difficulty urinating due to enlargement of the prostate gland", "Ask a doctor or pharmacist before use if you are": "taking the blood thinning drug warfarin"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:43.363528 · Updated: 2026-03-14T23:09:39.646164