DR. SIMI NIGHTTIME COLD AND FLU- acetaminophen 325 mg, dextromethorphan hbr 15 mg, doxylamine succinate 6.25 mg capsule, liquid filled

Drug Labeling and Warnings

Drug Details [pdf]

Drug Facts Active ingredients (in each softgel)

Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg

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
customerservice@drsimi.com
www.drsimi.com

Carton labeling

INGREDIENTS AND APPEARANCE

DR. SIMI NIGHTTIME COLD AND FLU 
acetaminophen 325 mg, dextromethorphan hbr 15 mg, doxylamine succinate 6.25 mg capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85786-602
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
SORBITAN (UNII: 6O92ICV9RU)
POVIDONE (UNII: FZ989GH94E)

Product Characteristics
Color	green	Score	no score
Shape	OVAL (Oblong softgel capsule)	Size	20mm
Flavor		Imprint Code	604
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85786-602-24	2 in 1 CARTON	03/30/2026
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	03/30/2026

Labeler - Farmacias De Similares TX LLC (119489934)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma, Inc.		790523323	manufacture(85786-602)