Sanatos Nighttime Ms 6 (ple)

SPL v2

SPL

SPL Set ID 0a60326a-a17b-e843-e063-6394a90ac211

Route

ORAL

Published

Effective Date 2023-12-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (650 mg) Doxylamine (12.5 mg) Dextromethorphan (30 mg)

Inactive Ingredients

Anhydrous Citric Acid Fd&c Green No. 3 Food Yellow 3 Free Acid Sucralose Sodium Benzoate Sodium Citrate Sorbitol Solution Water D&c Yellow No. 10 Glycerin Propylene Glycol Xanthan Gum

Identifiers & Packaging

Pill Appearance

Color: green

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 30 mg Cough suppressant Doxylamine succinate 12.5 mg Antihistamine

Medication Information

Description

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

Uses

Temporarily relieves common cold/flu symptoms associated with

minor aches and pains
headache
sore throat
runny nose
cough due to minor throat and bronchial irritation
sneezing
temoprarily reduces fever

Section 55105-1

Active ingredients (in each 30 mL)	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:

adults take more than 4 doses in 24 hours, which is the maxium daily amount
child takes more than 3 doses in 24 hours
taken with other drugs containing acetaminophen
adult has 3 or more alcoholic drinks everyday 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

adults & children 12 years & over	30 mL every 4 hours, do not exceed (child) 3 doses and (adult) 4 doses in 24 hours
children under 12 years	ask a doctor

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.

Questions?

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

Distributed By:

Pharmadel

New Castle, DE 19720

www.pharmadel.com

Facebook/PHARMADELUSA

Other Informaiton

each 30 mL contains: sodium 10 mg
store between 68-77°F (20-25°C)

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

excitability may occur, especially in children
may cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect
avoid alcoholic beverages
use caution when driving a motor vehicle or operating machinery

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
any 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
has glaucoma
has cough that occurs with too much phlegm (mucus)
has a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
has trouble urinating due to enlarged prostate gland
is a child with pain of arthritis

Ask A Doctor Or Pharmacist Before Use If User Is

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Structured Label Content

Uses

Temporarily relieves common cold/flu symptoms associated with

minor aches and pains
headache
sore throat
runny nose
cough due to minor throat and bronchial irritation
sneezing
temoprarily reduces fever

Section 55105-1 (55105-1)

Active ingredients (in each 30 mL)	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:

adults take more than 4 doses in 24 hours, which is the maxium daily amount
child takes more than 3 doses in 24 hours
taken with other drugs containing acetaminophen
adult has 3 or more alcoholic drinks everyday 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

adults & children 12 years & over	30 mL every 4 hours, do not exceed (child) 3 doses and (adult) 4 doses in 24 hours
children under 12 years	ask a doctor

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.

Questions?

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

Distributed By: (Distributed by:)

Pharmadel

New Castle, DE 19720

www.pharmadel.com

Facebook/PHARMADELUSA

Other Informaiton (Other informaiton)

each 30 mL contains: sodium 10 mg
store between 68-77°F (20-25°C)

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)

excitability may occur, especially in children
may cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect
avoid alcoholic beverages
use caution when driving a motor vehicle or operating machinery

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
any 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.)

Ask A Doctor Before Use If User (Ask a doctor before use if user)

has a sodium-restricted diet
has liver disease
has glaucoma
has cough that occurs with too much phlegm (mucus)
has a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
has trouble urinating due to enlarged prostate gland
is a child with pain of arthritis

Ask A Doctor Or Pharmacist Before Use If User Is (Ask a doctor or pharmacist before use if user is)

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "Temporarily relieves common cold/flu symptoms associated with minor aches and pains headache sore throat runny nose cough due to minor throat and bronchial irritation sneezing temoprarily reduces fever", "55105-1": "Active ingredients (in each 30 mL) 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: adults take more than 4 doses in 24 hours, which is the maxium daily amount child takes more than 3 doses in 24 hours taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks everyday 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 adults & children 12 years & over 30 mL every 4 hours, do not exceed (child) 3 doses and (adult) 4 doses in 24 hours children under 12 years ask a doctor", "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.", "Questions?": "+1-866-359-3478 (M-F) 9AM – 5PM EST or www.pharmadel.com", "Distributed by:": "Pharmadel New Castle, DE 19720 www.pharmadel.com Facebook/PHARMADELUSA", "Other informaiton": "each 30 mL contains: sodium 10 mg store between 68-77°F (20-25°C)", "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", "When using this product": "excitability may occur, especially in children may cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery", "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 any 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 has glaucoma has cough that occurs with too much phlegm (mucus) has a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema has trouble urinating due to enlarged prostate gland is a child with pain of arthritis", "Ask a doctor or pharmacist before use if user is": "taking the blood thinning drug warfarin taking sedatives or tranquilizers"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:24.512371 · Updated: 2026-03-14T23:01:57.446196