Drug Facts Active Ingredients (In Each Softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
Dr. Simi Nighttime Cold And Flu Capsule, Liquid Filled
FDA Label NDC 85786-602
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Farmacias De Similares Tx Llc for the product Dr. Simi Nighttime Cold And Flu (NDC 85786-602). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts active ingredients (in each softgel), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
| Acetaminophen 325 mg | Pain reliever/ fever reducer |
| Dextromethorphan HBr 15 mg | Cough suppressant |
| Doxylamine succinate 6.25 mg | Antihistamine |
Uses
temporarily relieves common cold/flu symptoms:
■ cough due to minor throat & bronchial irritation
■ sore throat
■ headache
■ minor aches & pains
■ fever
■ runny nose & sneezing
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
■ more than 8 softgels in 24 hrs, 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.
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.
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
■ cough that occurs with too much phlegm (mucus)
■ a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
■ trouble urinating due to enlarged 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
■
do not exceed recommended dosage
■ excitability may occur, especially in children
■ marked drowsiness may occur
■ avoid alcoholic drinks
■ be careful when driving a motor vehicle or operating machinery
■ alcohol, sedatives & tranquilizers may increase drowsiness
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 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. Quick medical attention is critical for adults as well as children, even if you do not notice any signs or symptoms.
Directions
■ take only as directed (see Warnings)
■ do not exceed 4 doses per 24 hrs
| adults & children 12 years and over | 2 softgels with water every 6 hours |
| children 4 to under 12 years | ask a doctor |
| children under 4 years | do not use |
■ When using other daytime or nighttime products, carefully read each label to ensure correct dosing
Other Information
■ Store at room temperature 20-25°C (68-77°F)
■ avoid excessive heat
Inactive Ingredients
D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide
Questions Or Comments?
855-280-1079
Principal Display Panel
NDC: 85786-602-24
DR. SIMI
Nighttime Cold & Flu
Acetaminophen,
Dextromethorphan HBr,
Doxylamine Succinate
Pain Reliever / Fever Reducer
Cough Suppressant & Antihistamine
Multi-Symptom Relief: Aches, Fever, Sore Throat, Cough, Sneezing & Runny Nose
24 Softgels
*Compare to the active ingredients in Vicks® NyQuil™ Cold & Flu Nighttime Relief LiquiCaps™
*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademarks Vicks® NyQuil™ LiquiCaps™.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed by: FARMACIAS DE SIMILARES TX LLC
800 Brazos St Ste 260, Austin, TX, 78701, USA
[email protected]
www.drsimi.com
* Please review the disclaimer below.
