Sanatos Nighttime Ehl Powder (as)

Sanatos Nighttime Ehl Powder (as)
SPL v8
SPL
SPL Set ID 144aafcc-6ec2-a322-e063-6294a90afc27
Route
ORAL
Published
Effective Date 2024-03-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg) Phenylephrine (10 mg) Acetaminophen (650 mg)
Inactive Ingredients
Isopropyl Alcohol Water Acesulfame Potassium Aspartame Anhydrous Citric Acid D&c Yellow No. 10 Fd&c Blue No. 1 Fd&c Red No. 40 Maltodextrin Silicon Dioxide Sodium Citrate Sucrose Tribasic Calcium Phosphate

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 and pains
  • sore throat
  • headache
  • nasal congestion
  • runny nose
  • itchy nose and throat
  • 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
Diphenhydramine HCL 25 mg Antihistamine/ cough suppressant
Phenylephrine HCL 10 mg Nasal decongestant
Warnings

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

  • more than 6 doses 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
  • adults 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.
  • with any other product containing diphenhydramine, even one used on skin
Drug Facts

Drug Facts

Questions?

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

Distributed By:

PHARMADEL LC

New Castle, DE 19720

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, D&C yellow #10, eucalyptus honey lemon 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

  • may cause excitability, especially in children
  • use caution when driving a motor vehicle or operating machinery
  • may cause marked drowsiness
Stop Use and Ask Doctor If

  • nervousness, dizziness, or sleeplessness occur
  • redness or swelling is present
  • pain, cough, or nasal congestion persists or gets worse or last more than 7 days
  • fever gets worse or lasts more than 3 days
  • any new symptoms occur
  • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
Ask A Doctor Before Use If You
  • have liver disease
  • have heart disease
  • have high blood pressure
  • have thyroid disease
  • have diabetes
  • have glaucoma
  • have a breathing problem such as emphysema
  • have difficulty urinating due to an enlarged prostate gland
  • have a breathing problem such as emphysema or chronic bronchitis
  • are taking sedatives or tranquilizers
If Pregnant Or Breast Feeding,

ask a health 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 Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin

Structured Label Content

Uses

Temporarily relieves common cold/flu symptoms:

  • minor aches and pains
  • sore throat
  • headache
  • nasal congestion
  • runny nose
  • itchy nose and throat
  • 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
Diphenhydramine HCL 25 mg Antihistamine/ cough suppressant
Phenylephrine HCL 10 mg Nasal decongestant
Warnings

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

  • more than 6 doses 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
  • adults 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.
  • with any other product containing diphenhydramine, even one used on skin
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 LC

New Castle, DE 19720

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)

acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow #10, eucalyptus honey lemon flavors, FD&C blue #1, FD&C red #40, isopropyl alcohol, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate, water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

When Using This Product (When using this product)
  • do not exceed recommended dosage

  • may cause excitability, especially in children
  • use caution when driving a motor vehicle or operating machinery
  • may cause marked drowsiness
Stop Use and Ask Doctor If (Stop use and ask doctor if)

  • nervousness, dizziness, or sleeplessness occur
  • redness or swelling is present
  • pain, cough, or nasal congestion persists or gets worse or last more than 7 days
  • fever gets worse or lasts more than 3 days
  • any new symptoms occur
  • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
Ask A Doctor Before Use If You (Ask a doctor before use if you)
  • have liver disease
  • have heart disease
  • have high blood pressure
  • have thyroid disease
  • have diabetes
  • have glaucoma
  • have a breathing problem such as emphysema
  • have difficulty urinating due to an enlarged prostate gland
  • have a breathing problem such as emphysema or chronic bronchitis
  • are taking sedatives or tranquilizers
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Kepp Out of Reach of Children. (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 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


Raw Label Data

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