Indications and uses
temporarily relieves common cold/flu symptoms: • nasal congestion • cough due to minor throat & bronchial irritation • sore throat • headache • minor aches & pains • fever
Dr. Simi Daytime 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 Daytime Cold and Flu
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections
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 4 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.
Contacts and useful links#
Websitewww.drsimi.com
www.drsimi.com
www.drsimi.comLabel contents#
Full prescribing information#
Drug Facts Active ingredients (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Purpose
| Acetaminophen 325 mg | Pain reliever / fever reducer |
| Dextromethorphan HBr 10 mg | Cough suppressant |
| Phenylephrine HCl 5 mg | Nasal decongestant |
Uses
temporarily relieves common cold/flu symptoms:
• nasal congestion
• cough due to minor throat & bronchial irritation
• sore throat
• headache
• minor aches & pains
• fever
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
• thyroid disease
• high blood pressure
• trouble urinating due to enlarged prostate gland
• heart disease
• diabetes
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough as occurs with smoking, asthma or emphysema
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin.
When using this product
do not use more than directed.
Stop use and ask a doctor if
• pain, cough, or nasal congestion gets worse or lasts more than 7 days
• nervousness, dizziness, or sleeplessness occur
• 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 4 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
FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide
Questions or comments?
855-280-1079
Principal Display Panel
NDC: 85786-601-12
DR. SIMI
Daytime Cold & Flu
Acetaminophen,
Dextromethorphan HBr,
Phenylephrine HCl
Pain Reliever / Fever Reducer
Cough Suppressant & Nasal Decongestant
Multi-Symptom Relief. Aches, Fever, Sore Throat,
Cough, Nasal Congestion, Sinus Pressure
12 Softgels
*Compare to the active ingredients in Vicks® DayQuil™ Cold & Flu LiquiCaps™
*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® DayQuil™ LiquiCap™.
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
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1086997 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 1 |
| 1086997 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 1 |
| 1086997 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SY | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85786-601-12 | Dr. Simi Daytime Cold and Flu | 12 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 12 | 1 | |
| 85786-601-12 | Dr. Simi Daytime Cold and Flu | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | 1 |
Products#
Every source-derived product name is available through these pages.
- Dr. Simi Daytime Cold and Flu
- Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Phenylephrine HCl 5 mg
- GLYCERIN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- FD&C RED NO. 40
- GELATIN
- POVIDONE
- PROPYLENE GLYCOL
- WATER
- ACETAMINOPHEN
- TITANIUM DIOXIDE
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- SORBITOL
- POLYETHYLENE GLYCOL, UNSPECIFIED
- FD&C YELLOW NO. 6
- SORBITAN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 85786-601 | 85786-601-12 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCERIN | PDC6A3C0OX | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GELATIN | 2G86QN327L | IACT |
| POVIDONE | FZ989GH94E | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| SORBITOL | 506T60A25R | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Dr. Simi Daytime Cold and Flu | ACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 10 MG, PHENYLEPHRINE HCL 5 MG | Farmacias De Similares TX LLC | 4e448fd0-cb6b-b69b-e063-6394a90afde8 | 2026-03-30 | Warnings | 85786-601-12 85786-601 85786060112 4e448fd0-cb6c-b69b-e063-6394a90afde8 4e448fd0-cb6b-b69b-e063-6394a90afde8 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.