FDA.reportPublic FDA data

Dr. Simi Nighttime Cold & Flu

Manufacturer
Farmacias De Similares TX LLC | AptaPharma, Inc.
Effective date
2026-03-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:52:46

Label at a glance#

ProductDr. Simi Nighttime Cold and Flu
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, ACETAMINOPHEN
Label structure10 sections

Indications and uses

temporarily relieves common cold/flu symptoms: ■ cough due to minor throat & bronchial irritation ■ sore throat ■ headache ■ minor aches & pains ■ fever ■ runny nose & sneezing

Dosage and administration

■ 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

Label contents#

Full prescribing information#

Drug Facts Active ingredients (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg

Purpose

OTC - PURPOSE SECTION

Acetaminophen 325 mgPain reliever/ fever reducer
Dextromethorphan HBr 15 mgCough suppressant
Doxylamine succinate 6.25 mgAntihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:
■ cough due to minor throat & bronchial irritation
■ sore throat
■ headache
■ minor aches & pains
■ fever
■ runny nose & sneezing

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

■ 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

OTC - ASK DOCTOR SECTION

■ 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

OTC - ASK DOCTOR/PHARMACIST SECTION

■ taking sedatives or tranquilizers
■ taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

■ 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

OTC - STOP USE SECTION

■ 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

■ take only as directed (see Warnings)
■ do not exceed 4 doses per 24 hrs

adults & children 12 years and over2 softgels with water every 6 hours
children 4 to under 12 yearsask a doctor
children under 4 yearsdo not use

■ When using other daytime or nighttime products, carefully read each label to ensure correct dosing

Other information

OTHER SAFETY INFORMATION

■ Store at room temperature 20-25°C (68-77°F)
■ avoid excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

855-280-1079

Principal Display Panel

SPL UNCLASSIFIED SECTION

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
customerservice@drsimi.com
www.drsimi.com

Carton labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label - CartonLabel - Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1094549acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral CapsulePSN1
1094549acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSCD1
1094549APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DOXYLAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85786-602-24Dr. Simi Nighttime Cold and Flu12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED121
85786-602-24Dr. Simi Nighttime Cold and Flu2 in 1 CARTONCAPSULE, LIQUID FILLED21

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85786-60285786-602-24

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
D&C YELLOW NO. 1035SW5USQ3GIACT
SORBITAN6O92ICV9RUIACT
POVIDONEFZ989GH94EIACT
ACETAMINOPHEN362O9ITL9DACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. Simi Nighttime Cold and FluACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 15 MG, DOXYLAMINE SUCCINATE 6.25 MGFarmacias De Similares TX LLC4e5772ee-586c-6191-e063-6294a90a132d2026-03-30WarningsExact identifier
ndc (package): 85786-602-24
ndc (product): 85786-602
ndc11 (package): 85786060224
spl id: 4e5772ee-586d-6191-e063-6294a90a132d
spl set id: 4e5772ee-586c-6191-e063-6294a90a132d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.