Sanatos Nighttime ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE PHARMADEL LLC FDA Approved Uses Temporarily relieves cough-cold symptoms cough due to minor throat and bronchial irritation headache minor aches and pains runny nose sneezing itching of the nose or throat itchy, watery eyes due to hay fever temporarily reduces fever
FunFoxMeds box
Substance Acetaminophen
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredients and Purposes . Active ingredients (in each softgel) Purposes Acetaminophen 325 mg .............. Pain reliever/ fever reducer Dextromethorphan HBr 15 mg ...... Cough suppressant Doxylamine succinate 6.25 mg ..... Antihistamine
Inactive Ingredients
Inactive ingredients D&C yellow #10 FD&C blue #1 gelatin glycerin polyethylene glycol 400 povidone k-30 propylene glycol sorbitol sorbitan solution water
Strengths
325 mg 15 mg 6.25 mg
Treats Conditions
Uses Temporarily Relieves Cough Cold Symptoms Cough Due To Minor Throat And Bronchial Irritation Headache Minor Aches And Pains Runny Nose Sneezing Itching Of The Nose Or Throat Itchy Watery Eyes Due To Hay Fever Temporarily Reduces Fever
Pill Appearance
Shape: capsule Color: green Imprint: CF02

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
362O9ITL9D 9D2RTI9KYH V9BI9B5YI2
Packaging

Principal Display Panel PDP Sanatos Night

Package Descriptions
  • Principal Display Panel PDP Sanatos Night

Overview

Uses Temporarily relieves cough-cold symptoms cough due to minor throat and bronchial irritation headache minor aches and pains runny nose sneezing itching of the nose or throat itchy, watery eyes due to hay fever temporarily reduces fever

Indications & Usage

Uses Temporarily relieves cough-cold symptoms cough due to minor throat and bronchial irritation headache minor aches and pains runny nose sneezing itching of the nose or throat itchy, watery eyes due to hay fever temporarily reduces fever

Dosage & Administration

Directions Age Dose adults and children 12 years and older 2 softgels every 6 hours, do not exceed 8 softgels in a 24 hour period children 4 to under 12 years consult a doctor children under 4 years do not use

Warnings & Precautions
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 amount for this product 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. 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. Ask a doctor before use if you have liver disease glaucoma a cough that is accompanied by excessive phlegm (mucus) a persistent or chronic cough as occurs with smoking, asthma or emphysema a breathing problem such as emphysema or chronic bronchitis difficulty urinating due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin When using this product may cause marked drowsiness excitability may occur, especially in children alcohol, sedatives and tranquilizers may increase drowsiness effect avoid alcoholic drinks when taking this product 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 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 a rash or a persistent 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.
Purpose

Active ingredients (in each softgel) Purposes Acetaminophen 325 mg .............. Pain reliever/ fever reducer Dextromethorphan HBr 15 mg ...... Cough suppressant Doxylamine succinate 6.25 mg ..... Antihistamine

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.

When Using

When using this product may cause marked drowsiness excitability may occur, especially in children alcohol, sedatives and tranquilizers may increase drowsiness effect avoid alcoholic drinks when taking this product use caution when driving a motor vehicle or operating machinery

Stop Use & Ask a Doctor

Stop use and ask a doctor if pain or cough 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 a rash or a persistent headache that lasts. These could be signs of a serious condition.

Keep Out of Reach of Children

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.

Questions

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


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